Recall Z-0855-2024 ยท FMF Syringe, Piston
Cardinal Health 200, LLC
Cardinal Health Monoject, 20 mL Syringe Luer-Lock Tip Soft Pack, REF 1182000777
| Date | Feb 2, 2024 (initiated Dec 28, 2023) |
| Status | Open, Classified |
| Reason | Cardinal Health is expanding their previous product correction actions to a product removal of all sizes of Cardinal Health brand Monoject sterile Syringe Luer-Lock (1, 3, 6, 12, 20, 35, and 60 mL) and Cardinal Health brand Monoject sterile Enteral Syringes with the ENFit connection (1, 3, 6, 12, 35, and 60 mL) due to a change in manufacturing and rebranding efforts. |
| Root cause | Process change control |
| Action | Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT CORRECTION notice to its consignees on 12/28/2023 via FedEx. The notice explained the problem with the device, risk to patient, and requested the following actions be taken: 1. REVIEW your inventory for the affected product codes and lots. Location of product code and lot are shown in above listed table and below example labeling. 2. COMMUNICATE with all personnel that utilize the Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) that they should not be used with enteral syringe feeding pumps. 3. POST a copy of t |
| Distribution | Distribution US nationwide and Canada. Foreign distribution updated 9/6/2024 to only include Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.