Recall Z-1802-2020 ยท KCY Tourniquet, Pneumatic
Stryker Sustainability Solutions
Zimmer Tourniquet Cuff 30" (Blue), PLC Dual Port, Single Bladder, Item Number: 60-7070-105, UDI: 00885825013868, Reprocessed Tourniquet Cuff - Product Usage: Reprocessed tourniquet cuffs are indicated for use in patients who require surgery of the extremities with an expected duration of less than 90 minutes when temporary exsanguination of a limb is desired.
| Date | Oct 9, 2019 |
| Status | Terminated |
| Reason | Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force. |
| Root cause | Employee error |
| Action | Beginning 10/09/2019, the firm provided an "URGENT MEDICAL DEVICE RECALL" notification letter and attached Recall Effectiveness Check Form to the affected customers through the sales representatives. The notification letter instructed the customer to do the following: (1) Please check inventory for the devices from the affected lot. (2) Complete the Urgent Medical Device Recall Effectiveness Check Form (page 3) and indicate if any of the affected product remains in inventory. Return the completed form through one of the following methods: (a) email; (b) sales representative; or (c) via fax to |
| Quantity | 90 |
| Distribution | US Nationwide distribution including the states of SC, TX, UT, NY, AR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.