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 Recall Z-2758-2017 · Posted 2017-07-07
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Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodeKKX
Date Initiated2017-06-27
Date Terminated2019-03-29
Product Quantity528 each
Reason for Recall
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.
Firm Action
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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution - US (Nationwide including PR) and Canada
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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