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U.S. Department of Health and Human Services

Class 2 Device Recall Color Cuff

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  Class 2 Device Recall Color Cuff see related information
Date Initiated by Firm December 06, 2013
Date Posted January 06, 2014
Recall Status1 Terminated 3 on February 27, 2014
Recall Number Z-0630-2014
Recall Event ID 67040
Product Classification Torniquet, pneumatic - Product Code KCY
Product Stryker Color Cuff, REF 5921-034-135
Disposable Tourniquet Cuffs 34 in x 4 in (86 cm x 10 cm)
Single Bladder, Single Port, QuickConnect
Rx only, STERILE
Code Information Lot 50731155 Color code Purple
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact Kelly Jo Whipple
269-323-7700
Manufacturer Reason
for Recall		 The Color Cuff¿ Sterile Disposable Tourniquet Cuffs with Quick-Connect Fitting may have an incorrect end-connector. A customer reported having received a luer connector instead of a quick connect fitting. An incorrect connector may lead to an inoperable system due to incompatibility with the Smart Pump.
FDA Determined
Cause 2		 Component change control
Action Distributor was notified by E-mail 11/26/2013, with follow-up UPS letters sent to Hospital Risk/ Materials Managers identifying the product, reason for the recall, and risk. The notice asked consignees to find and quarantine all implicated product, with hospitals requested to complete the Business Reply Form and FAX to 866-521-2762. Stryker will email a pre-paid shipper and credit all accounts. Question and concerns should be addressed to Kelly Jo Whipple 269-389-2921 or kellyjo.whipple@stryker.com
Quantity in Commerce 5 boxes (50 units)
Distribution US Distribution: including states of: MI, OH, and TX.
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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