Femoral Angiography Drape Bulk Non-Sterile — Class II medical device recall Z-1304-2021
Terminated recall by Cardinal Health 200, LLC, reported 2021-03-31, distributed nationwide. Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these produ
| Recall number | Z-1304-2021 |
|---|---|
| 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 | 2021-02-25 |
| Classified | 2021-03-24 |
| Reported by FDA | 2021-03-31 |
| Terminated | 2024-01-09 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA |
| Quantity | 83,213 units |
| Lot numbers | 2450ER1, 2450ER2, 2460ER1, 2460ER2, 2470ER1, 2470ER2, 2480ER1, 2480ER2, 2510ER1, 2510ER2, 2520ER1, 2520ER2, 2530ER1, 2530ER2, 2540ER1, 2600ER2, 2610ER1, 2610ER2, 2620ER1, 2620ER2, 2650ER1, 2650ER2, 2660ER1, 2660ER2, 2670ER1, 2670ER2, 2690ER1, 2690ER2, 2720ER1, 2720ER2, 2730ER1, 2730ER2, 2740ER1, 2740ER2, 2750ER1, 2750ER2, 2760ER1, 2760ER2, 2820ER1, 2820ER2 and 24 more |
| Model numbers | 29560NC |
Product
Femoral Angiography Drape Bulk Non-Sterile
Reason for recall
Cardinal Health has determined that a manufacturing variance in a plastic film used to manufacture these products is causing the drapes and leggings to stick , which may prevent the products from being unfolded and applied properly.
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-1304-2021. 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.