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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Tourniquet Cuff

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  Class 2 Device Recall Zimmer Tourniquet Cuff see related information
Date Initiated by Firm October 09, 2019
Create Date April 27, 2020
Recall Status1 Terminated 3 on January 14, 2021
Recall Number Z-1802-2020
Recall Event ID 85330
Product Classification Tourniquet, pneumatic - Product Code KCY
Product 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.
Code Information Lot Number 10237165 
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
1810 W Drake Dr
Tempe AZ 85283-4327
For Additional Information Contact
888-888-3433
Manufacturer Reason
for Recall		 Tourniquet cuffs are potentially mislabeled. If used may lead to (1) Device misuse during procedure (2) Inadequate Limb Compression Force.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 90
Distribution US Nationwide distribution including the states of SC, TX, UT, NY, AR
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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