Bard Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. The Bard Soft Mesh patch is a non-absorbable, sterile pr

FDA device recall Z-2239-2011 · posted 2011-05-23 · Terminated

Recall details

Recalling firm

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

Reason for recall

Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6"

Action taken

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.

Root cause

Labeling mix-ups

Status

Terminated

Product code

FTL

Quantity affected

198 units

Distribution

Nationwide Distribution

Date initiated

2011-04-25

Date posted

2011-05-23

Date terminated

2011-10-28

Location

Warwick, RI

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