BARD Ventrio Small Oval Hernia Patch 3.1" x 4.7" Product Code: 0010211 Indicated for use in the reconstruction of soft t

FDA device recall Z-0422-2011 · posted 2010-11-19 · Terminated

Recall details

Recalling firm

Davol, Inc., Sub. C. R. Bard, Inc.

Reason for recall

Mislabeled: Hernia Patch may be a different size than on the product label

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.

Root cause

Packaging process control

Status

Terminated

Product code

FTL

Quantity affected

196 units

Distribution

Nationwide Distribution

Date initiated

2010-10-15

Date posted

2010-11-19

Date terminated

2011-10-27

Location

Warwick, RI

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