Bard Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008. Intended for use
FDA device recall Z-0144-2012 · posted 2011-11-01 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Reason for recall
- Mislabeled: Bard Ventralex" ST Medium Circle was packaged in a pre-printed carton identified for a Bard Ventralex" ST Large Circle.
- Action taken
- Davol Inc. issued an Urgent; Medical Device Recall letter on 10/4/11 for the mislabeled Bard Ventralex ST Medium Circle. The letter identified the affected product and explained the reason for recall. Customers are to immediately examine their inventory and quarantine any affected product. In addition, if any product was further distributed then those customers should be notified of the recall as well. Accounts are to contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. The attached recall effectiveness check form should be completed and returned. Questions should be directed towards Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Services & Support Department at 1-800-562-0027.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 96 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2011-10-04
- Date posted
- 2011-11-01
- Date terminated
- 2013-09-20
- Location
- Warwick, RI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VENTRALEX ST HERNIA PATCH (K101928) | C.R. Bard, Inc. | 2011-03-23 |