Recall Z-2757-2017
Cardinal Health 200, LLC · initiated June 27, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STERILE R, 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.
Codes / lots: Lot 16LFS235, expires November 1, 2021
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.
FDA-determined cause: Mixed-up of materials/components
Action taken
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.
Details
- Recall number
- Z-2757-2017
- Initiated
- June 27, 2017
- Posted by FDA
- July 7, 2017
- Terminated
- March 29, 2019
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Quantity
- 1591 each
- Distribution
- Worldwide Distribution - US (Nationwide including PR) and Canada
- Recalling firm
- Cardinal Health 200, LLC, Waukegan, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2758-2017 Class II | Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Cardinal…Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot number… | 06/27/2017Terminated |