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U.S. Department of Health and Human Services

Class 2 Device Recall Color Cuff Disposable Tourniquet Cuff

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  Class 2 Device Recall Color Cuff Disposable Tourniquet Cuff see related information
Date Initiated by Firm November 06, 2019
Create Date December 02, 2019
Recall Status1 Terminated 3 on November 19, 2021
Recall Number Z-0593-2020
Recall Event ID 84316
Product Classification Tourniquet, pneumatic - Product Code KCY
Product Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.
Code Information GTIN: 37613154599296, Lot Numbers 60180374, 60181194
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
Manufacturer Reason
for Recall		 There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
FDA Determined
Cause 2		 Under Investigation by firm
Action Urgent Medical Device Recall Notification letters dated 11/6/19 were sent to customers. Actions to be taken: 1. Immediately review this Recall Notification and the Business Reply Form. 2. Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any Color Cuff Disposable Tourniquet Cuffs identified in this Notification. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Return the completed BRF via fax (8665212762) or email to kara.spath@stryker.com. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward copies of this Notification and the BRF to all affected locations, for each location to complete and return. Even if you have distributed all product to another location, please complete a BRF and indicate each location that received product. 5. If the BRF for your facility indicates that recalled product is currently on hand, a shipping label will be provided which should be used to return recalled product. Upon receipt of the recalled product, a credit will be applied to your account.
Quantity in Commerce 16,380 total
Distribution Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.
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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