BardVentralex" Hernia Patch Medium Circle with Strap Diameter 6.4cm /2.5",\ Catalog #0010302, lot number HUTL1283. The B
FDA device recall Z-2124-2011 · posted 2011-05-02 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Sub. C. R. Bard, Inc.
- Reason for recall
- Mislabeled: Bard Medium Ventralex Hernia Patch 6.4cm /2.5" packaged in a pre-printed carton identified for a Bard Ventralex Small Circle 4.3cm /1.7"
- Action taken
- Davol sent an Urgent: Medical Device Recall letter on April 11, 2011, via FedeX Priority Overnight to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and remove and return the recalled lot. Distributors were requested to notify their accounts. For questions contact the 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
- 146 units
- Distribution
- Nationwide Distribution - USA including AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MD, MI, MO, MT, NC, NJ, NV, NY, OH, OR, PA, RI, SC, TN, TX, VA, WA, and WV.
- Date initiated
- 2011-04-11
- Date posted
- 2011-05-02
- Date terminated
- 2011-10-27
- Location
- Warwick, RI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 (K021736) | C.R. Bard, Inc. | 2002-07-16 |