FDA Device recall Z-1303-2021
Femoral Angiography Drape 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 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-1303-2021 |
| 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 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 29560; Lot number's: 20LQR067 (expiration date: 2025-11-01) and 20MQR023 (expiration date: 2025-12-01) |
|---|
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-1303-2021%22
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