Z-2239-2011

Bard Soft Mesh 4"x6" (10cm x 15cm) Flat

Name: Z-2239-2011 Bard Soft Mesh 4"x6" (10cm x 15cm) Flat
Creator: Davol, Inc., Sub. C. R. Bard, Inc.
Published: 2011-04-25
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2011-04-25 / Terminated / root cause: labeling and UDI

FDA source

Davol, Inc., Sub. C. R. Bard, Inc. began a recall of Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design... on 2011-04-25. The reason FDA records is "Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2239-2011
Status: Terminated
Initiated: 2011-04-25
Posted: 2011-05-23
Terminated: 2011-10-28
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The device classification name is "Mesh, Surgical, Polymeric".
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6"
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Davol issued an URGENT: MEDICAL DEVICE RECALL notification letter to customers dated April 25, 2011, informing them the recall involving a single lot of the BARD Soft Mesh - Lot# HUUF0530. This recall has been initiated because this lot number may contain a different size patch than is indicated. Customers were instructed to immediately examine inventory and quarantine product subject to recall. Customers are asked to identify and notify their customers to whom recalled product may have been further distributed. A Recall Effectiveness Check reply form should be completed and returned to Davol via fax (401-825-8753). For directions on returning product or for questions regarding the recall, contact Davol Customer Service Department at 1-800-556-6275 or C.R. Bard's Medical Services & Support Department at 1-800-562-0027.
Quantity in commerce: 198 units
Distribution: Nationwide Distribution
Product codes and lots: Lot# HUUF0530

Product code FTL

K033814Class IIBard Soft Mesh, Models 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007C.R. Bard, Inc. / cleared 2004-03-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)