Z-0820-2014Class II

Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System...

Name: Z-0820-2014 Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System...
Creator: Davol, Inc., Subs. C. R. Bard, Inc.
Published: 2014-01-03
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2014-01-03 / Terminated / root cause: labeling and UDI

FDA source

Davol, Inc., Subs. C. R. Bard, Inc. began a recall of Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh... on 2014-01-03. FDA classified it as Class II and gives the reason as "Product labeling does not match product configuration". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0820-2014
Classification: Class II
Status: Terminated
Initiated: 2014-01-03
Posted: 2014-01-23
Terminated: 2015-12-23
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: Product labeling does not match product configuration.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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,
Quantity in commerce: 46
Distribution: Nationwide Distribution including CA, PA, IL, VA, FL, GA, NY, TX, MO, NE, IN, NM, OH, IA.
Product codes and lots: Lot# HUXG0491, HUXH0295

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0820-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0819-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23
Z-0820-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-29	2014-01-23

Product code FTL

K102766Class IIComposix L/p Mesh with Echo Ps Positioning SystemC.R. Bard, Inc. / cleared 2010-12-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)