Multidex Powder, Maltodextrin Wound Dressing, Catalog Numbers: 46-701, 46-702, 46-703, 46-704, 46-702-1, 46-703-1, 46-70
FDA device recall Z-0544-04 · posted 2004-02-24 · Terminated
Recall details
- Recalling firm
- DeRoyal Surgical Tray
- Reason for recall
- Hydrophilic powder wound dressing, sterilized at a dosage which subsequently failed a sterility audit, was distributed.
- Action taken
- The firm notified their consignees via letter sent UPS 2nd day air on 01/19/2004 requesting return of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- NAC
- Quantity affected
- 2,495 units
- Distribution
- Nationwide and Europe
- Date initiated
- 2004-01-19
- Date posted
- 2004-02-24
- Date terminated
- 2004-10-13
- Location
- New Tazewell, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MULTIDEX HYDROPHILIC WOUND DRESSING (K945000) | Lange Medical Products, Inc. | 1994-11-17 |