BARD Mesh Pre-shaped (1.8" x 4.0"/4.5cm x 10cm) Product code: 0112700 Intended use: Bard Pre-shaped mesh is a pre-shaped
FDA device recall Z-0446-2011 · posted 2010-11-23 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Reason for recall
- Mislabeled: The labeled BARD Mesh Pre-shaped product code 0112700 (1.8" x 4.0"/4.5cm x 10cm), but the contents are the BARD Mesh Large Pre-shaped product code 0113700 (2.4" x 5.4"/6.0cm x 13.7cm).
- Action taken
- Davol issued an "URGENT MEDICAL DEVICE RECALL" letter on October 15, 2010, via Overnight Delivery to all customers. The letter describes the product, the problem and the action to be taken by the customers. The customers were instructed to immediately examine their inventory and quaratine the product; identify and notify customers they may have further distributed the product to of this recall; contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product, and complete and return the attached EFFECTIVENESS CHECK form via fax to 1-401-825-8753. If you have an questions, please 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
- Process control
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 144 units
- Distribution
- Nationwide distribution
- Date initiated
- 2010-10-15
- Date posted
- 2010-11-23
- Date terminated
- 2011-10-27
- Location
- Warwick, RI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED (K052155) | C.R. Bard, Inc. | 2005-10-20 |