FDA Device recall Z-1449-2022
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R
- FDA Device
- Class II
- terminated
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R by Aesculap Implant Systems, citing packaging seal integrity not validated resulting in a lack of sterility assurance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1449-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-01 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aesculap Implant Systems |
| Distribution | CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA, WI |
Product
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
Reason
Packaging seal integrity not validated resulting in a lack of sterility assurance.
Identifiers
| code_info | UDI-DI (GTIN): 04038653067862, lots 551953371, 52024524, 52097698, 52172460, 52249972, and 52340448. |
|---|
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-1449-2022%22
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