Infusomat UNIV. 15 DROP PUMP SET W/ 0.2 FILTER- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362050
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2381-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 15 DROP PUMP SET W/3 SAFELINE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363030
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2386-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat SPACE PUMP IV SET, 127 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480255
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2395-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490564
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2404-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2376-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat SPACE PUMP IV SET W/2 CARESITE, CKVLV -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490103
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2400-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363420
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2387-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV.15DROP PUMP SET W/3 SAFELINE LL-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362032
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2378-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat SPACE PUMP SET 15 DROP W/2 SAFEDAY-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362420
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2382-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 15 DROP PUMP SET, 2 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363421
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2388-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490361
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2402-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat SPACE PUMP IV SET , 120 IN.- Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 362432
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2384-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat 60DROP METRISET PUMP, 3 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363422
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2389-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat 60 DROP METRISET PUMP SET,3 SFLINE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363010
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2385-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV 60 DROP PUMP SET, W/2 CARESITE INJ. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number : 490104
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2401-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat 60 DROP METRISET PUMP SET, 3 CARESITES Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490101
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2398-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 15 DROP PUMP SET, 3 ULTRASITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 363230
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2403-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 15 DROP PUMP SET W 3 CARESITE L.L. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/ Catalog Number: 490100
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2397-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363424
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2391-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 15 DROP PUMP SET, 3 CARESITE, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363433
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2393-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat UNIV. 60 DROP PUMP SET, 2 CARESITES, ASV-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 363423
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2390-2024July 24, 2024Allentown, PA
B. Braun Medical, Inc.
Class IIOngoing
Infusomat SPACE PUMP IV SET 15D, 110 IN. -Used with an electrically-powered infusion pump for intravenous (IV) administration of medication Model/Catalog Number: 480254
Reason: Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime...
Z-2394-2024July 24, 2024Allentown, PA
Zyno Medical LLC
Class IIOngoing
Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps
Reason: Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump...
Z-2263-2024July 10, 2024Natick, MA
OptumHealth Care Solutions LLC
Class IOngoing
Optum Nimbus II Plus, Model number AAA-00170; Ambulatory Infusion Pump
Reason: Nimbus II Plus, Infusion Pump Systems, manufactured by InfuTronix, are being removed the from the market due to multiple potential failure modes, including battery failure, upstrea...
Z-1811-2024May 29, 2024Marietta, GA
Baxter Healthcare Corporation
Class IIOngoing
Spectrum IQ Infusion pump, Product Code 357009
Reason: There is a potential for cracks on the mount of the front panel of the device.