BARD Ventrio Small Oval Hernia Patch 3.1" x 4.7" Product Code: 0010211 Indicated for use in the reconstruction of soft tissue deficiencies such as for the repair of hernias.
This recall has been terminated (originally issued November 19, 2010).
- Recall Initiated
- October 15, 2010
- Posted
- November 19, 2010
- Terminated
- October 27, 2011
- Recall Number
- Z-0422-2011
- Quantity
- 196 units
- Firm Location
- Warwick, RI
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled: Hernia Patch may be a different size than on the product label
Distribution
Nationwide Distribution
Lot / Code Info
Lot Number: HUTL1369
Root Cause
Packaging process control
Action Taken
Davol notified accounts by an Urgent: Medical Device Recall letter on 10/15/10 via overnight delivery. The letter stated that the product maybe a different size than indicated on the product label. It also identified the affected product. Accounts are requested to examine their inventory, remove, and return recalled product. Customers are to notify any of their customers that they may have further distributed the affected product to by including a copy of the recall notice. Customers should contact Davol Customer Service 1-800-556-6275 for instructions on how to return the affected product. Customers are also requested to complete and fax back the attached fax sheet to 1-401-825-8753. If there are any additional questions, customers should contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Service Support Department at 1-800-562-0027.