—#90324

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.

FDA product code: GAG — Stapler, Surgical
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Catalog Number: FS-35W, Lot Numbers: 090203-SH and 091008-SH.

Why it was recalled

The sterility of the staplers is questionable.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Cardinal Health
Address: 1430 Waukegan Rd, Mc Gaw Park, Illinois 60085-6726

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2010-04-01
Posted by FDA: 2010-05-19
Terminated: 2011-08-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #90324. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.