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".
Recall
- Recall Number
- Z-2239-2011
- Event Number
- 58685
- Firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- FEI Number
- 1213643
- Product Code
- FTL
- Status
- Terminated
- Root Cause
- Labeling mix-ups
- Initiated
- April 25, 2011
- Posted
- May 23, 2011
- Terminated
- October 28, 2011
- Address
- 100 Crossings Blvd, Warwick, RI, 02886-2850
Description
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".
Mislabeling: complaints of product labeled as Bard Soft Mesh 4" x 6" containing Bard Soft Mesh 6" x 6"
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.
Nationwide Distribution
198 units