Bard Ventrio Small Oval Hernia Patch 8cm X 12cm (3.1" x 4.7"), Warwick, RI Product Code: 0010211 The Ventrio Hernia Patch is a self-expanding non-absorbable, sterile prosthesis, containing two primary layers of monofilament polypropylene mesh stitched with PTFE monofilament to an ePTFE sheet, forming a positioning pocket. The Ventrio Hernia Patch is indicated for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.
This recall has been terminated (originally issued May 4, 2010).
- Recall Initiated
- April 8, 2010
- Posted
- May 4, 2010
- Terminated
- October 27, 2011
- Recall Number
- Z-1536-2010
- Quantity
- 198 units
- Firm Location
- Warwick, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled: Product labeled as Small Oval (3.1" x 4.7") may contain Small Circle (3.0")
Distribution
Nationwide distribution
Lot / Code Info
REF 0010211 Lot DATB0015
Root Cause
Labeling mix-ups
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.