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

Recall number

Z-0422-2011

Recalling firm

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

Product

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.

Status

Terminated

Initiated

2010-10-15

Posted

2010-11-19

Terminated

2011-10-27

Reason

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

Root cause

Packaging process control

Action

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.

Quantity

196 units

Distribution

Nationwide Distribution

Lot, serial or model codes

Lot Number: HUTL1369

510(k) numbers

["K081777"]

PMA numbers

not on file

Product code

FTL

Firm FEI

1213643

Firm city

Warwick

Firm state

RI

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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