—#187757

Product

Nonsterile Femoral Angiography Drape with Single Pouch, Catalog Number 29525N - 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.

FDA product code: PUI — Drape, Surgical, Exempt
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: Lot Numbers: 0141ER1, 0141ER2, 2400ER2, 2410ER1, 2410ER2, 2540ER2, 2550ER1, 2550ER2, 2580ER1, 2580ER2, 2590ER1, 2590ER2, 2600ER1, 2760ER2, 2880ER1, 2940ER1, 2940ER2, 3070ER1, 3080ER1, 3530ER1, 3530ER2

Why it was recalled

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 (FDA determination)

Nonconforming Material/Component

Action the firm took

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.

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2021-05-21
Terminated: 2024-01-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187757. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.