Recall Z-2405-2024 ยท KCY Tourniquet, Pneumatic
Stryker Sustainability Solutions
REF: 60-7070-005, Zimmer, Tourniquet Cuff 30" (Blue), Luer-Lock Dual Port, single Bladder, RxOnly
| Date | Jul 17, 2024 (initiated May 31, 2024) |
| Status | Open, Classified |
| Reason | Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder. |
| Root cause | Employee error |
| Action | On June 14, Stryker Sustainability Solutions issued a "Urgent: Medical Device Recall" Notification to affected consignees via mail. Stryker ask consignees to take the following actions: 1) Please check your inventory for the devices from the affected lots and remove them from their point of use. a. Please complete the Urgent Medical Device Recall Business Reply Form (page 3) and indicate if any of the affected product remains in your inventory. Please return this completed form to Email: SSSPFA@stryker.com This form must be completed and returned to Stryker even if no affected product is fou |
| Quantity | 90 units |
| Distribution | US Nationwide distribution in the states of CA, CO, IL, MI, OR, WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.