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Terminated

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.

FDA Recall Z-1610-2010 · Posted 2010-05-19

Recalling FirmCardinal Health
Recall StatusTerminated
Product CodeGAG
Date Initiated2010-04-01
Date Terminated2011-08-17
Product Quantity1,638 units

Reason for Recall

The sterility of the staplers is questionable.

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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