Drug recall
Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping…
FDA recall event 90475 · Class II · Aesculap Implant Systems LLC
Key facts
| Event ID | 90475 |
|---|---|
| Recall numbers | Z-1449-2022 |
| Recalling firm | Aesculap Implant Systems LLC |
| Product type | Devices |
| Products | Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Packaging seal integrity not validated resulting in a lack of sterility assurance. |
| Initiation date | Oct 1, 2019 |
| Report date | Jul 27, 2022 |
| Termination date | Jun 6, 2024 |
| City | Center Valley |
| State | PA |
| Country | United States |
| FEI number | 2916714 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: