Recall Z-0310-2025 ยท MEG Syringe, Antistick
Cardinal Health 200, LLC
Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 1188100777
| Date | Nov 8, 2024 (initiated Sep 25, 2024) |
| Status | Open, Classified |
| Reason | Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack have demonstrated incompatibility with needleless Intravenous (IV) connectors. Cardinal Health recommends that they not be used for administration of IV push insulin via needleless connector. |
| Root cause | Under Investigation by firm |
| Action | Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL to its consignees on 09/25/2024 via overnight mail. The notice explained the issue, risk to health, and requested the following actions: 1. REVIEW inventory for the affected product code and lots. 2. COMMUNICATE with all personnel who utilize the Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack that it should not be used for administration of IV push insulin via needleless connector. 3. POST a copy of this notification in your storeroom where the product is stored. 4. NOTIFY any customers to w |
| Quantity | 371,326 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.