Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code: 0010211 The Ventrio Hernia Patc
FDA device recall Z-1536-2010 · posted 2010-05-04 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Reason for recall
- Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0")
- Action taken
- An "URGENT RECALL: BARD VENTRIO SMALL OVAL HERNIA PATCH (LOT DATB0015" letter dated April 8, 2010, was issued by the firm (Davol) to all customers via FedEx overnight with signature required. The letter describes the product, problem and action to be taken by the customers. The customers were instructed to: please examine their inventory and immediately discontinue use of this lot; contact the Davol Customer Service Department at 1-800-556-6275 for instructions on how to return product to firm; complete and fax the EFFECTIVENESS CHECK sheet to 1-401-825-8753, and forward a copy of this letter, if they are a distributor, to their customers who have received the product and lot number. All products returned will be held at the Davol, Warwick location. Please contact your Davol Territory Manager or C.R. Bard's Medical Service Support Department at 1-800-562-0027 if you have any other questions.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 198 units
- Distribution
- Nationwide distribution
- Date initiated
- 2010-04-08
- Date posted
- 2010-05-04
- Date terminated
- 2011-10-27
- 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 |
|---|---|---|
| VENTRIO HERNIA PATCH (K081777) | C.R. Bard, Inc. | 2008-09-29 |