Lot/Batch Numbers:  23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

General Hospital and Personal Use Devices

2

Yes

US Distribution to states of: NC, OH, FL, and MD.

Catheter, Percutaneous || The Arrow Single-Lumen Catheter permits venous access to the central circulation.

Lot/Batch Numbers:  23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285

General Hospital and Personal Use Devices

2

Yes

US Distribution to states of: NC, OH, FL, and MD.

Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days || The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.

Lot #: 4941411

General Hospital and Personal Use Devices

2

Yes

Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX

Peripherally Inserted Central Catheters (PICC), UPN H965750141, Catalog # 75-014 || The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology 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, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring

Lot #: 4945781

General Hospital and Personal Use Devices

2

Yes

Nationwide Distribution to CA, FL, GA, HI, LA, MI, MN, MO, NV, OH & TX

Peripherally Inserted Central Catheters (PICC), UPN H965750191, Catalog # 75-019 || The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The BioFlo PICC with ENDEXO Technology and BioFlo PICC with ENDEXO and PASV Valve Technology 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, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

Batch/Lot: 505722, 5056512

General Hospital and Personal Use Devices

2

Yes

Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.

Xcela Power Injectable PICC Maximal Barrier Nursing Kit || The Maximal Barrier Nursing Kits are Tandem Pack Convenience Kits packaged with a NMI PICC and accessories. The Xcela Power Injectable PICC is 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

Batch/Lot: 1) 5018265, 2) 5024787, 3) 5021872, 4) 5020644, 5) 5026458, 6) 5026468

General Hospital and Personal Use Devices

2

Yes

Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.

BioFlo PICC with ENDEXO Technology Maximal Barrier Nursing Kit - || 1) UPN # H965750121/Catalog No: 5018265, 2) UPN # H965750131/Catalog No:5024787, 3) UPN # H965750141/Catalog No: 5024787, 4) UPN # H965750241/Catalog No: 5020644, 5) UPN # H965750325/Catalog No: 5026458, 6) UPN # H965750355/Catalog No: 5026468 || The BioFlo PICCs with ENDEXO Technology 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, nutrients; the sampling of blood; for central venous pressure monitoring and for power injection of contrast media

Batch/Lot: 5018263, 5020646, 5046472, 5051539

General Hospital and Personal Use Devices

2

Yes

Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.

BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 || The BioFlo PICCs with ENDEXO and PASV Valve Technology 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, nutrients; the sampling of blood; and for power injection of contrast media

Material #  ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01552-LS, PI-01552-LS5, PI-01552-SS, PL-05041, PL-05041, PL-05052, PR-05041, PR-05041, PR-05041-T, PR-05042, ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01351-SS, PI-01451-LS, PI-01451-LS5, PI-01451-SS, PI-01451-SS, PI-0-1552-LS

General Hospital and Personal Use Devices

2

Yes

Nationwide Distribution

Vascular catheter introduction kit || The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.

OP7543 (lot 00855421005666 01211086) and OP7544 (lot 00855421005673 013110816)

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan

OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right

Lot 4908974

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.

Xcela PICC Kit with ENDEXO and PASV Valve Technology, XCELA PASV 5F DL 55CM MST-70 Nitinol KIT PG, UPN H965251250, Catalog No. 25-125 || The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology 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, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

Serial Number NGV526743H

General Hospital and Personal Use Devices

3

Yes

IL

SynchroMed II implantable drug infusion pump, Model 8637-40,

MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution to PR and Panama

9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter || The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media

Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844

General Hospital and Personal Use Devices

2

Yes

US Distribution

The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.

Material number: ASK-45552-RWJ4  Device Listing D213817

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution - US (nationwide) and Canada

1) Pressure Injectable ARROW(R) PICC Kit with Chlorag+ard(R) Technology || The Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology is indicated for short-term or long-term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media, and allows for central venous pressure monitoring

Material number: EU-04041-HPMSB, EU-05052-HPMSB, EU-05041-HPMSB Device Listing D000801

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution - US (nationwide) and Canada

Arrow Pressure Injectable PICC Kit || Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days || The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

All

General Hospital and Personal Use Devices

3

Yes

Nationwide Distribution

PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. || The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).

Lot/Batch Number: 23F16M0263

General Hospital and Personal Use Devices

2

Yes

Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet || The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

Lot/Batch Number: 23F16K0055

General Hospital and Personal Use Devices

2

Yes

Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

ARROW¿ PICC powered by ARROW¿ VPS¿ Stylet || The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

Lot/Batch Number: 23F16L0021

General Hospital and Personal Use Devices

2

Yes

Nationwide Distribution to AZ, CA, MA, MO, NC, NY, OR & SD

ArrowADVANTAGE5" Pressure Injectable Peripherally Inserted Central Catheter (PICC) || The Pressure Injectable PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, power injection of contrast media and allows for central venous pressure monitoring

Device Listing # D149129 Material # ASK-45552-RWJ4 PR-45552-HPHNL

General Hospital and Personal Use Devices

2

Yes

Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok

Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology

Lot # MHGB030 Exp. Date 2020-07-30

General Hospital and Personal Use Devices

2

Yes

Arabia, Australia, Israel, Brunei & Jamaica

6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 || Product Usage: || Indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media.

Lot 4904007

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.

XCELA PASV 5F DL 55CM IR-145 Nitinol Wire KIT PG, UPN H965251260, Catalog No. 25-126 || The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology 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, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

Lot 4903452

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.

XCELA PASV 5F DL 55CM MST-70 KIT PG, UPN H965457320, Catalog No. 45-732 || The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology 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, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

Lot 4899431

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.

XCELA PASV 5F DL 55CM IR-145 KIT PG, UPN H965457330, Catalog No. 45-733 || The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology 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, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.

Lot 4906931

General Hospital and Personal Use Devices

2

Yes

Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.

Bio-Stable 5F SL-55CM IR-145 Kit Valved PG, UPN H965458180, Catalog No. 45-818 || The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC with ENDEXO and PASV Valve Technology 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, nutrients; the sampling of blood; and for power injection of contrast media. Non-Valve lumens are indicated for central venous pressure monitoring.