—#157506

Product

Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal Health, Waukegan, IL A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.

FDA product code: KKX — Drape, Surgical
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot 16LUS317, expires November 1, 2021

Why it was recalled

Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number 9414, Lot 16LUS317 do not match the drape packaged inside.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Cardinal Health sent an Urgent Product Recall letter dated June 27, 2017, to all affected consignees. In the letter, the firm requested the following actions be taken: 1. Inspect your inventory for the affected product code and lot number (listed on the package) 2. segregate and quarantine all on-hand product 3. Return the enclosed acknowledgment form via fax to 847-689-9101 ir614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product you've quarantined or discarded. 4. Notify any customers to whom may have distributed or forwarded product affected by this product. 5. Contact the appropriate Customer Service group to arrange for return and credit of any affected product: Hospital - 800-964-5227 Federal Government - 800-444-1166 Distributor - 600-635-6021 All other customers - 888-444-5401 For questions regarding this recall call 800-327-7503.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 1500 S Waukegan Rd, Waukegan, Illinois 60085-6728

Distribution

Distribution pattern: Worldwide Distribution - US (Nationwide including PR) and Canada

Timeline

Recall initiated: 2017-06-27
Posted by FDA: 2017-07-07
Terminated: 2019-03-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #157506. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.