Recall Z-0147-2024 ยท FMF Syringe, Piston
Cardinal Health 200, LLC
Monoject" 12 mL Syringe Luer-Lock Tip Soft Pack
| Date | Oct 26, 2023 (initiated Sep 20, 2023) |
| Status | Open, Classified |
| Reason | Demonstrated recognition and compatibility issues with syringe infusion pumps. |
| Root cause | Vendor change control |
| Action | Cardinal Health notified customers on about 09/20/2023 via "URGENT MEDICAL DEVICE PRODUCT CORRECTION" letter sent FedEx next day delivery. Customers were instructed to: 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" Luer-Lock Tip syringes (1, 6, 12, 20, 35 and 60 mL) that they should not be used with syringe infusion pumps. 3. POST a copy of this notification in your storeroom where the product is stored |
| Quantity | 3,084,300 units |
| Distribution | US Nationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.