FDA Device recall Z-1304-2021
Femoral Angiography Drape Bulk Non-Sterile
- FDA Device
- Class II
- terminated
- Published 2021-03-31
On 2021-03-31 the FDA classified a Class II recall of Femoral Angiography Drape Bulk Non-Sterile by Cardinal Health 200, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1304-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-25 |
| Published | 2021-03-31 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Femoral Angiography Drape Bulk Non-Sterile
Reason
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.
Identifiers
| code_info | Catalog Number 29560NC; Lot number's: 2450ER1, 2660ER1, 2960ER1, 2450ER2, 2660ER2, 2960ER2, 2460ER1, 2670ER1, 2970ER1,…Catalog Number 29560NC; Lot number's: 2450ER1, 2660ER1, 2960ER1, 2450ER2, 2660ER2, 2960ER2, 2460ER1, 2670ER1, 2970ER1, 2460ER2, 2670ER2, 2970ER2, 2470ER1, 2690ER1, 3030ER1, 2470ER2, 2690ER2, 3030ER2, 2480ER1, 2720ER1, 3040ER1, 2480ER2, 2720ER2, 3040ER2, 2510ER1, 2730ER1, 3080ER2, 2510ER2, 2730ER2, 3090ER1, 2520ER1, 2740ER1, 3090ER2, 2520ER2, 2740ER2, 3100ER1, 2530ER1, 2750ER1, 3100ER2, 2530ER2, 2750ER2, 3150ER1, 2540ER1, 2760ER1, 3160ER1, 2600ER2, 2760ER2, 3170ER1, 2610ER1, 2820ER1, 3180ER1, 2610ER2, 2820ER2, 3210ER1, 2620ER1, 2830ER1, 3290FR1, 2620ER2, 2830ER2, 3490FR1, 2650ER1, 2860ER1, 2650ER2, 2950ER2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1304-2021%22
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