Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a
FDA device recall Z-2413-2012 · posted 2012-09-20 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Subs. C. R. Bard, Inc.
- Reason for recall
- Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh
- Action taken
- Davol issued an "URGENT: MEDICAL DEVICE RECALL" letter dated September 4, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter advises customers to examine their inventory and quarantine affected product for return to the firm. Customers were asked to complete and return a Recall Effectiveness Check Form. Contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Services & Support Department at 1-800-562-0027 if you have any questions.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 49 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2012-09-04
- Date posted
- 2012-09-20
- Date terminated
- 2013-09-03
- 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 |
|---|---|---|
| VENTRALIGHT ST MESH (K101851) | Davol Inc., Sub. C. R. Bard, Inc. | 2010-07-15 |