Device Recall Vaxcel

  • Model / Serial
    Lots 1192332, 1198106, 1202172, 1204956, 1206895, 1208684, 1214359, 1214651, 1219666, 1227904, 1230056, 1231144, 1233993, 1239665, 1243253, 1245545, 1248436, 1251234, 1252586, 1257028, 1258107, 1262111, 1265536, 1267698, 1268135, 1275216, 1278343, 1286359, 1288651, 1292866, 1295866, 1305978, 1308308, 1314993, 1321214, 1329618, 1341521, 1349623, 1351954, 1357024, 1359288, 1362390, 1363949, 1365530, 1371855, 1373199, 1374542, 1377845, 1379701, 4001736, 4007727, 4010947, 1282267D
  • Product Classification
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
  • Product Description
    Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Standard Port with PASV Valve and 8F Polyurethane Catheter (1.6 mm/2.6 mm), REF Catalog No. 45-362, UPN Product No. M001453620, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Navilyst Medical, Inc, 10 Glens Falls Technical Park, Glens Falls NY 12801
  • Manufacturer Parent Company (2017)
  • Source
    USFDA

36 devices with a similar name

Learn more about the data here

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Model / Serial
    Batch/Lots: 1) 4732403, 4776151, 4792223, 4810671 with Use By 2015-08-31.
  • Product Classification
  • 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
  • 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
  • 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
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