FDA Device recall Z-2036-2021
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as pr…
- FDA Device
- Class II
- terminated
- Published 2021-07-14
On 2021-07-14 the FDA classified a Class II recall of Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - Product Usage: intended to be used as pr… by Cardinal Health 200, citing 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 a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2036-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-05-21 |
| Published | 2021-07-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cardinal Health 200 |
| Distribution | US |
Product
Nonsterile Sterile Cesarean Birth Drape with Dual Layer Anesthesia Screen, Catalog Number 29442N - 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
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.
Identifiers
| code_info | Lot Numbers: 0121QR2, 0391RR1, 3070QR1, 3280QR1, 3280QR2, 3290QR1, 3290QR2, 3300QR1, 3300QR2, 3310QR1, 3310QR2, 3320QR1, 3570QR1, 3570QR2 |
|---|
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-2036-2021%22
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