Convertors Three Quarter Sheet (Drape Sheet), catalog #29350; Allegiance Healthcare Corporation, McGaw Park, IL 60085 US
FDA device recall Z-0576-03 · posted 2003-02-25 · Terminated
Recall details
- Recalling firm
- Allegiance Healthcare Corp.
- Reason for recall
- The product labeled as sterile had not been through its sterilzation cycle.
- Action taken
- Recalled by letter dated 1/22/03. The accounts were informed of the non-sterile product, requested to examine their inventories for the affected lot, to return any product found for credit and to sub-recall the product from their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- KKX
- Quantity affected
- 320 drapes
- Distribution
- New Jersey, Georgia, Washington and Florida
- Date initiated
- 2003-01-22
- Date posted
- 2003-02-25
- Date terminated
- 2003-12-03
- Location
- Mcgaw Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL DRAPES (K002419) | Allegiance Healthcare Coporation | 2000-08-15 |