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.
This recall has been terminated (originally issued May 19, 2010).
- Company
- Cardinal Health
- Recall Initiated
- April 1, 2010
- Posted
- May 19, 2010
- Terminated
- August 17, 2011
- Recall Number
- Z-1610-2010
- Quantity
- 1,638 units
- Firm Location
- Mc Gaw Park, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The sterility of the staplers is questionable.
Distribution
Nationwide Distribution
Lot / Code Info
Catalog Number: FS-35W, Lot Numbers: 090203-SH and 091008-SH.
Root Cause
Packaging process control
Action Taken
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.
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