Recall Z-0664-2022 ยท KCY Tourniquet, Pneumatic
Stryker Sustainability Solutions
REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder
| Date | Jan 21, 2022 |
| Status | Terminated |
| Reason | Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs. |
| Root cause | Labeling mix-ups |
| Action | On February 4, 2022, Stryker issued an "Urgent: Medical Device Recall notification" to all affected customers. In addition to informing consignees about the recalled product, the firm ask customers to take the following actions: 1.) Please check your inventory for the devices from the affected lot and remove them from their point of use. 2.) 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 through one of the following methods: a. Email: SSSPFA@stryker.com b. |
| Quantity | 40 units |
| Distribution | US: KS OK TX OUS: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.