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  • Device 3821
  • Manufacturer 31827
  • Event 4589
  • Implant 424
Device Recall 9F Plastic Dual Port
  • Model / Serial
    Model No. MR592090A, MR592090P; with Lot Nos.:  MAKT120 EXP. DATE 04/28/2012, MAXH410 EXP. DATE 06/28/2014, MAXF610 EXP. DATE 10/28/2014, MBFC140 EXP. DATE 05/28/2016, MBGH020 EXP. DATE 08/28/2016, MBHS100 EXP. DATE 11/28/2016, MAKT130 EXP. DATE 04/28/2012, MBAQ860 EXP. DATE 07/28/2015, MBHP980 EXP. DATE 11/28/2016, MBKJ110 EXP. DATE 03/28/2017
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.
  • Product Description
    9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.
  • Manufacturer
    Medical Components, Inc dba MedComp
  • 1 Event
    • Recall of Device Recall 9F Plastic Dual Port
Device Recall Codman 3000 Series Refill Set
  • Model / Serial
    Lot numbers: 14B114CT, 14E011CT, and 14E366CT
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution-US (nationwide) and the countries of Canada, France, Germany, and Switzerland.
  • Product Description
    CODMAN 3000 Series Refill Set- Huber needles. || Used in combination with the CODMAN 3000 Series Constant Flow Implantable Pump || CATALOG NO. : AP-07014 || Each CODMAN 3000 Refill Kit contains 2 (two) 22 Gauge x 1.5 Huber Point Needles which are used in conjunction with a 50 mL Calibrated Syringe Barrel, Tubing Set and Stopcock for pump refills. || .
  • Manufacturer
    Codman & Shurtleff, Inc.
  • 1 Event
    • Recall of Device Recall Codman 3000 Series Refill Set
Device Recall PowerPICC SOLO Catheter
  • Model / Serial
    Lot No: REYK1763, Item No. 1194108D
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microintroducer || The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
  • Manufacturer
    Bard Access Systems
  • 1 Event
    • Recall of Device Recall PowerPICC SOLO Catheter
Device Recall PowerPICC SOLO Catheter
  • Model / Serial
    Lot No: REYK1762, Item No. 1295108D
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microintroducer || The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
  • Manufacturer
    Bard Access Systems
  • 1 Event
    • Recall of Device Recall PowerPICC SOLO Catheter
Device Recall PowerPICC SOLO Catheter
  • Model / Serial
    Lot No: REYK1764, Item No. 9194108
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroducer (with Lidocain) || The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
  • Manufacturer
    Bard Access Systems
  • 1 Event
    • Recall of Device Recall PowerPICC SOLO Catheter
Device Recall PowerPICC SOLO Catheter
  • Model / Serial
    Lot No: REYK1761, Item No. 9194108D
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution
  • Product Description
    PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sherlock) || The PowerPICC Solo catheters are intended for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.
  • Manufacturer
    Bard Access Systems
  • 1 Event
    • Recall of Device Recall PowerPICC SOLO Catheter
Device Recall Celsite Implantable Access Port System
  • Model / Serial
    Lot number: 36896615
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    CA and NY only.
  • Product Description
    Celsite Implantable Access Port System, model ST301. The Celsite Implantable Access Port Systems (Celsite port systems) are implantable port and catheter systems that allow safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medication and fluids. The Celsite system consists of an access port with a silicone septum, which is connected to a catheter using a connection ring. The triangular shaped access port has a low profile nose, finger stops on the side of the housing, and a round base. Celsite access ports have suture holes or suture zones to secure placement during implantation.
  • Manufacturer
    B. Braun Interventional Systems
  • 1 Event
    • Recall of Device Recall Celsite Implantable Access Port System
Device Recall Bard Access Marketing Brochures
  • Model / Serial
    The brochures were purchased from the vendor on 04/14/2015, Code S120667R0
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed to domestic and foreign conference attendees.
  • Product Description
    Marketing brochures for the PowerPICC and PowerPICC SOLO catheters
  • Manufacturer
    Bard Access Systems
  • 1 Event
    • Recall of Device Recall Bard Access Marketing Brochures
Device Recall Arrow Intl PICC Kits with PeelAway Sheath Component
  • Model / Serial
    Product Codes: ASK-02041-SEH1 CA-05052-HP CDC-34052-VPS EU-05552-HPMSB ASK-04001-DU4   CA-05052-HPX CDC-35041-VPS FR-04041 ASK-04052-AC CDC-02041-MK1A CDC-35052-VPS FR-04041-CF ASK-05041-LM4   CDC-04041-HPK1A CDC-35541-VPS FR-05041 ASK-05052-SFL CDC-04052-HPK1A CDC-35552-VPS FR-05041-CF ASK-05541-MS2   CDC-05041-HPK1A EU-04041-HP FR-05541-CF ASK-05541-MS3  CDC-05052-HPK1A EU-04041-HPMSB PI-01451-LS ASK-15552-LM2 CDC-05541-HPK1A  EU-04052-HPMSB PI-01451-LS5 ASK-15552-MS3 CDC-05542-PK1A EU-05041-HPMSB PK-01451-WS ASK-35041-JHVA CDC-05552-HPK1A EU-05052-HPMSB PK-01451-WSSP CA-05041-HP  CDC-15552-HPK1A EU-05541-HP UK-05041-HPMIN CA-05041-HPX CDC-34041-VPS   EU-05541-HPMSB  lot numbers: 23F14H0517 23F14J0077 23F15F0662 71F14M0678 71F15A1660 23F14L0941 23F15C2282 23F14H0328 71F15A0395 71F15B1938 23F14B1232 23F14D0456 23F14C0598 71F15C0214 71F15D0235 23F15A1523 23F14C0059 23F14F1505 71F15D0053 71F14L1345 23F14A1779 23F14E1213 23F14K1025 71F15D1075 71F15D1077 23F14G1295 23F14G1470 23F15B0400 23F14C0576 71F15E0455 23F14J0973 23F14H1111 23F14F1507 23F14F0115 71F14K1571 23F14M0791 23F14J0613 23F14M0440 23F14G1130 71F14F1786 23F15A1171 23F15A0149 23F14F0364 23F14F0504 71F14G1690 23F14H0848 23F15D0507 23F14L0838 23F14D0713 71F14F1844 23F14F0370 23F14J1512 23F14H0331 23F14C0575 71F14E2043 23F15C2435 23F15C0302 23F15B0401 23F14D0724 71F14K0639 23F14L0090 23F15B0399 23F15D0938 23F14E1493 71F15B1937 23F14G1072 23F14C1096 23F15D0313 23F14F0716 71F14L0577 23F14M0774 23F14H1112 23F14D0281 23F14M1010 71F14L1347 23F15D0622 23F14C0640 23F14E1325 23F15D1420 71F15A1302 23F14H0920 23F14F1497 23F14G0091 71F14H0351 71F15B0662 23F14J1382 23F15A1857 23F14D0282 71F14H0947 71F15D0681 23F15A0038 23F15D0830 23F14H0498 71F14G0365 71F14J1860 23F15C1236 23F14G1471 23F14H1312 71F14H1396 71F14F1785 23F14E1373 23F14M0038 23F14D0285 71F14J0869 71F15A0300 23F14E1124 23F14J1312 23F14B1144 71F14K0082 71F15C2011 23F14F0441 23F15A1604 23F14G0095 71F14F1358 23F14J0437 23F14G1226 23F15B2002 23F14H1314 71F14K0622 23F14K0406 23F15B0065 23F15E1025 23F14E1469 71F14K1332 23F14B0935 23F14J1546 23F14A1419 23F14E1261 71F15A1289 23F14H1535 23F14L0882 23F14C0643 23F14J1390 71F15C1137 23F15A0278 23F15C1237 23F14F1504 23F14E1262 71F15A1984 23F15D0907 23F14H0301 23F14J0221 23F14H0510 71F15B0638 23F14F0326 23F14E1093 23F14J1513 23F14B1128 71F15D0272 23F14K1016 23F14J0415 23F14L1144 23F14C0473 71F15A0152 23F14G1587 23F14B0844 23F14E0791 23F14D0308 71F14M0141 23F15A1813 23F14L0810 23F14E0406 23F14J1391 71F15D1059 23F14D0042 23F14K1361 23F14E1215 23F14F0780 23F14D0217 23F15D0284 23F14M0484 23F14G1458 23F14H0512 23F14D1125 23F14J0358 23F14L0187 23F15D1232 71F14K0081 23F14B1013 23F14F0106 23F15D0881 23F14J0617 71F14J1087 23F14F0510 23F15A0388 23F14J1048 23F14K0537 71F14K0628 71F14K1569 23F15D0046 23F14J0076 23F15A0695 71F14L0323 71F15D0052 71F14G0670 23F15D0882 23F14L1146 71F15D0234 71F14J1086 71F14K1035 23F15F0193 23F15C0992 71F14L0762 71F14H0374 71F14K0409 23F15A0691 71F15B0648 71F14K1198 71F14L1351
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    US Nationwide Distribution and internationally to Canada
  • Product Description
    PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound || Product Usage: || catheter, intravascular, therapeutic, ultrasound
  • Manufacturer
    Arrow International Inc
  • 1 Event
    • Recall of Device Recall Arrow Intl PICC Kits with PeelAway Sheath Component
Device Recall Ascenda Intrathecal Catheter Model 8781
  • Model / Serial
    N558983006
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Internationally to Japan.
  • Product Description
    Medtronic, Model 8781 Ascenda" Intrathecal Catheter kit, Rx Only, Sterile Ethylene Oxide.
  • Manufacturer
    Medtronic Neuromodulation
  • 1 Event
    • Recall of Device Recall Ascenda Intrathecal Catheter Model 8781
Device Recall Vaxcel PICC with PASV Catheter Kit
  • Model / Serial
    Batch/Lots: 1) 4732402, 4745359, 4824107, 4827333, 4835750, 4860987 & 48698433, 2) 4772713, 4786763, 4790018, 4817452 & 3) 4725793, 4745367, 4748673, 4756297, 4765394, 4773295, 4784468, 4788536 & 4845665 with Use By 2016-04-30.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY. || The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Vaxcel PICC with PASV Catheter Kit
Device Recall Vaxcel PICC with PASV Introducer Kit
  • Model / Serial
    Batch/Lots:1) 4714745 with Use By 2016-03-31. Batch/Lots: 2) 4745413, 4819467, 4827954, 4725425 & 4726948 with Use By Date Range 2016-03-31 to 2016-11-30.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY. || The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Vaxcel PICC with PASV Introducer Kit
Device Recall Vaxcel PICC with PASV IR145 Kit
  • Model / Serial
    Batch/Lots: 1) 4748893, 4766101, 4773293 & 4814220 with Use By Range 2016-05-31 to 2016-10-31.  Batch/Lots: 2) 4752348, 4784466, 4735032, 4738833, 4765395 & 4814222 with Use By Range 2016-05-31 to 2016-07-31.  Batch/Lots: 3) 4752881, 4765393 & 4942171 with Use By Range 2016-05-31 to 2017-09-30.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY || The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Vaxcel PICC with PASV IR145 Kit
Device Recall Vaxcel PICC with PASV MST30 Kit
  • Model / Serial
    Batch/Lots: 1) 4724924, 4724925 & 4730412 with Use By 2016-03-31.  Batch/Lots: 2) 4724929, 4724923, 4725426, 4730400 & 4753766 with Use By Range 2016-03-31 to 2016-07-31.  Batch/Lots: 3) 4724927 Use By 2016-03-31.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY. || The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Vaxcel PICC with PASV MST30 Kit
Device Recall Vaxcel PICC with PASV MST60 Kit
  • Model / Serial
    Batch/Lots: 1) 4724945, 4731137, 4738296, 4895232, 4912062, 4933353, 2) 4731139, 4738302, 4748674, 4776152, 3) 4721239, 4784467, 4810672, 4812161, 4821239, 4821511, 4824106, 4830612, 4832722, 4836599, 4724949, 4724950, 4738298, 4738299, 4773297, 4773298, 4786764, 4823438, 4829478, 4832723,4845209, 4724926 & 4734253 with Use By Date Range 2016-03-31 to 2017-09-30.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY || The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Vaxcel PICC with PASV MST60 Kit
Device Recall Vaxcel PICC with PASV Introducer Kit
  • Model / Serial
    Batch/Lots: 1) 4732403, 4776151, 4792223, 4810671 with Use By 2015-08-31.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY || The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Vaxcel PICC with PASV Introducer Kit
Device Recall Vaxcel PICC with PASV Intermediate Safety MST Kit
  • Model / Serial
    Batch/Lots: 1) 4738829, 2) 4732404, 4749417, 4774464, 4793677, 4819468, 4829479, 3) 4725435, 4745700, 4755306, 4764067, 4801103 & 4827331 with Use By Date 2016-04-30 to 2016-10-31.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980 || The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Vaxcel PICC with PASV Intermediate Safety MST Kit
Device Recall Xcela PICC with PASV Valve Technology Catheter Kit
  • Model / Serial
    Batch/Lots: 4815673 Use By 2016-10-31
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY || The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Xcela PICC with PASV Valve Technology Catheter Kit
Device Recall Xcela PICC with PASV Valve Technology, IR145 Kit
  • Model / Serial
    Batch/Lots: 4712504, 4732394 & 4800179  Use By 2016-09-30
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY || The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Xcela PICC with PASV Valve Technology, IR145 Kit
Device Recall Xcela PICC with PASV Valve Technology
  • Model / Serial
    Batch/Lots: 4721803, 4732391, 4767156, 4768679, 4784455, 4789995, 4809602, 4728559, 4752329, 4768072 & 4783738. Use By Date Range 2016-03-31 to 2016-10-31
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY || The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Xcela PICC with PASV Valve Technology
Device Recall Xcela PICC with PASV Valve Technology, Intermediate MST45 Kit
  • Model / Serial
    Batch/Lots: 4718004, 4783051, 4788340 & 4796128. Use By Date Range 2016-03-31 to 2016-08-31
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440 Rx ONLY || The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Xcela PICC with PASV Valve Technology, Intermediate MST45 Kit
Device Recall Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit
  • Model / Serial
    Batch/Lots: 4743467 & 4759480  Use By 2016-04-30 and 2016-05-31
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY || The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit
Device Recall Xcela Hybrid PICC with PASV Valve Technology, IR145 Kit
  • Model / Serial
    Batch/Lots: 4759481, 4807952, 4746868, 4752404 & 4788361.  Use By 2015-08-31
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY || The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Xcela Hybrid PICC with PASV Valve Technology, IR145 Kit
Device Recall Xcela Hybrid PICC with PASV Valve Technology, MST70 Kit
  • Model / Serial
    Batch/Lots: 4762475, 4780075, 4797006, 4807953, 4730240 & 4757886. Use By Date 2016-03-31 to 2016-09-30.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY || The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Xcela Hybrid PICC with PASV Valve Technology, MST70 Kit
Device Recall Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST45 Kit
  • Model / Serial
    Batch/Lots: 4719661, 4746382, 4752893, 4790027, 4815993, 4830605, 4735062, 4759816, 4775599, 4785918, 4812167 & 4819162. Use By Date Range 2016-03-31 to 2016-10-31
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution US (Nationwide) Internationally to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
  • Product Description
    Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY || The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
  • Manufacturer
    Navilyst Medical, Inc., an AngioDyamics Company
  • 1 Event
    • Recall of Device Recall Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST45 Kit
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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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