Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-
FDA device recall Z-0819-2014 · posted 2014-01-23 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Subs. C. R. Bard, Inc.
- Reason for recall
- Product labeling does not match product configuration.
- Action taken
- Davol, Inc., Subs. C. R. Bard, Inc.sent a customer notification letter on January 3, 2013, to all affected customers via Fedex to inform consignees that the Instructions for Use (IFU) and graphic contained on the inside of the product carton bottom references two features added to the inflation tube that are not present on the product they received. Please contact the Davol Customer Service Department at 1-800-556-6275 or C. R. Bards Medical Services & Support Department at 1-800-562-0027 if you have any questions. Consignees are asked to complete an effectiveness check form and return it via fax to 401-825-8753. For questions regarding this recall call 800-556-6275,
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- FTL
- Quantity affected
- 19
- Distribution
- Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
- Date initiated
- 2014-01-03
- Date posted
- 2014-01-23
- Date terminated
- 2015-12-23
- Location
- Warwick, RI
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM (K102766) | C.R. Bard, Inc. | 2010-12-16 |