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U.S. Department of Health and Human Services

Class 2 Device Recall Disposable Skin Stapler 35 Wide

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  Class 2 Device Recall Disposable Skin Stapler 35 Wide see related information
Date Initiated by Firm April 01, 2010
Date Posted May 19, 2010
Recall Status1 Terminated 3 on August 17, 2011
Recall Number Z-1610-2010
Recall Event ID 55215
Product Classification Stapler, surgical - Product Code GAG
Product Disposable Skin Stapler - 35 Wide; Surgical Skin Stapler; Rx, sterile, single use skin stapler, individually packaged in a thermo-formed tray with a Tyvek lid, 5 trays per box; Distributed by Cardinal Health, Dublin, OH 43017, Made in China; catalog number FS-35W.

Designed to close incisions during a surgical procedure.
Code Information Catalog Number: FS-35W, Lot Numbers: 090203-SH and 091008-SH. 
Recalling Firm/
Manufacturer		 Cardinal Health
1430 Waukegan Rd
Mc Gaw Park IL 60085-6726
For Additional Information Contact Michele B. Donatich R.N.
847-473-1500
Manufacturer Reason
for Recall		 The sterility of the staplers is questionable.
FDA Determined
Cause 2		 Packaging process control
Action Cardinal Health issued an "Urgent: Product Recall" letter dated April 1, 2010 to all customers who may have received affected product. Customers were instructed to immediately quarantine any affected inventory, return the notification acknowledgement form and return the product to the firm. For further information, contact Cardinal Health Customer Service at 1-888-444-5440.
Quantity in Commerce 1,638 units
Distribution Nationwide Distribution
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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