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Terminated

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.

FDA Recall Z-1802-2020 · Posted None

Recall StatusTerminated
Product CodeKCY
Date Initiated2019-10-09
Date Terminated2021-01-14
Product Quantity90

Reason for Recall

Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.

Firm 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 480-763-5345. The form must be completed and returned even if no affected product is found. If any of the affected products have been forwarded to additional facilities (including but not limited to distribution warehouses), please contact these facilities and communicate this recall to them. Please instruct these facilities to complete the Recall Effectiveness Check Form (page 3) and return the completed form either via email email, sales representative, or via fax to 480-763-5345. If the form indicates that any affected product remains in your inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to the facility for all devices that are returned prior to January 1, 2020.

Root Cause

Employee error

Distribution Pattern

US Nationwide distribution including the states of SC, TX, UT, NY, AR

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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