Recall Z-2757-2017 ยท KKX Drape, Surgical, Antimicrobial
Cardinal Health 200, LLC
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.
| Date | Jul 7, 2017 (initiated Jun 27, 2017) |
| Status | Terminated |
| Reason | 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 | Mixed-up of materials/components |
| 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 prod |
| Quantity | 1591 each |
| Distribution | Worldwide Distribution - US (Nationwide including PR) and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.