Recall Z-2404-2024 ยท FPA Set, Administration, Intravascular
B. Braun Medical, Inc.
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
| Date | Jul 17, 2024 (initiated Jun 17, 2024) |
| Status | Open, Classified |
| 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, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood. |
| Root cause | Process control |
| Action | B. Braun Medical Inc. (BBMI) is issuing a voluntary Urgent Medical Device Correction letter via US Postal Service Certified Mail with registered return receipt on 6/17/24. Letter states reason for recall, health risk and action to take: Corrective actions are being implemented to prevent these concerns in future manufacturing lots through optimization of the disks that provide the sealing function within these valves. Until such time as lots with these corrective actions are available, users are asked to follow the "Interim Measures for Users." A follow-up communication will be provided to use |
| Quantity | 2352 units |
| Distribution | Worldwide distribution - US Nationwide and the country of Canada. |
| FDA record | Open on fda.gov |