Recall Z-2031-2021 ยท PUI Drape, Surgical, Exempt
Cardinal Health 200, LLC
Sterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525 - Product Usage: intended to be used as protective patient coverings, such as to isolate the site of a surgical incision from microbial and other contamination.
| Date | May 21, 2021 |
| Status | Terminated |
| Reason | The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the drapes to stick, which may prevent the products from being unfolded and applied properly. Sold in single sterile and bulk non-sterile configurations. |
| Root cause | Nonconforming Material/Component |
| Action | The firm initiated the recall by letter on 05/20/2021. The letter explained the issue and the hazard, and requested the return of the units. |
| Quantity | 574 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.