Recall Z-1783-2026 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Cook Incorporated
COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0018, Order Number G21053; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0042, Order Number G34914; Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0047, Order Number G44431; Reference Part Number C-UTLMY-701J-ABRM-CU
| Date | Apr 6, 2026 (initiated Mar 5, 2026) |
| Status | Open, Classified |
| Reason | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| Root cause | Incorrect or no expiration date |
| Action | Cook Medical issued an URGENT: MEDICAL DEVICE RECALL to its consignee on 3/5 2026 via courier or email. The notice explained the issue, potential risk to health, and requested the following: Actions to be Taken by the Customer 1. Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowled |
| Quantity | 1872 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081113 | COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS Cook, Inc., Jul 30, 2008 |