Sterile Femoral Angiography Drape — Class II medical device recall Z-2037-2021
Terminated recall by Cardinal Health 200, LLC, reported 2021-07-14, distributed nationwide. The plastic film used to manufacture these Angiography Drape and Cesarean Birth Drape products is causing the
| Recall number | Z-2037-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cardinal Health 200, LLC, Waukegan, IL, United States |
| Recall initiated | 2021-05-21 |
| Classified | 2021-07-08 |
| Reported by FDA | 2021-07-14 |
| Terminated | 2024-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 5,342 units |
| Reason classes | sterility |
| Lot numbers | 20LRS055, 20MMR062, 20MRS073, 21ARS042 |
Product
Sterile Femoral Angiography Drape, Catalog Numbers: a) 29460, b) 29456 - 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2037-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.