Recall Z-0850-2024 ยท PNR Enteral Syringes With Enteral Specific Connectors
Cardinal Health 200, LLC
Cardinal Health Monoject, 60mL Enteral Syringe (purple) - For Use with ENFit Connection System, REF 460SE
| Date | Feb 2, 2024 (initiated Dec 28, 2023) |
| Status | Open, Classified |
| Reason | The listed lots of Cardinal Health Monoject Enteral Syringes with ENFit (6, 12, 35, 60 mL) have recognition and compatibility issues with certain syringe enteral feeding pumps. As a result, Cardinal Health recommends that they not be used with enteral syringe feeding pumps. |
| 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 |
| Quantity | 397676 units |
| 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
| K190502 | ENFit Oral / Enteral Syringe Jiangsu Caina Medical Co.,Ltd, Aug 6, 2019 |