Bard 3D Max Mesh, Left large , Sterile Pre-formed Knitted Polypropylene Product Code: 0151531 Bard 3D Max Mesh is an ana
FDA device recall Z-0935-2009 · posted 2009-01-28 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Reason for recall
- Mislabeled: Product labeled as Left large, may contain a Right Large
- Action taken
- Davol issued a letter notification dated 12/25/08 via Federal Express requesting accounts discontinue use, remove product from inventory and return product. For additional information, contact Davol at 1-401-463-7000.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 232 units
- Distribution
- Nationwide
- Date initiated
- 2008-12-08
- Date posted
- 2009-01-28
- Date terminated
- 2012-05-02
- Location
- Warwick, RI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| USHER'S MARLEX TUBULAR MESH (K792281) | Davol, Inc. | 1979-11-27 |