Z-0191-2015Class II

Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where...

Name: Z-0191-2015 Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where...
Creator: Davol, Inc., Subs. C. R. Bard, Inc.
Published: 2014-10-08
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2014-10-08 / Terminated / root cause: labeling and UDI

FDA source

Davol, Inc., Subs. C. R. Bard, Inc. began a recall of Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue... on 2014-10-08. FDA classified it as Class II and gives the reason as "The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug". 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-0191-2015
Classification: Class II
Status: Terminated
Initiated: 2014-10-08
Posted: 2014-11-07
Terminated: 2015-12-23
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Bard PerFix Light Plug The Bard PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
Product code: FTL Mesh, Surgical, Polymeric
Reason for recall: The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the Bard Small PerFix Light Plug.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Davol Inc. (Subsidiary of C.R. Bard, Inc)sent Customer Notification letters on Friday, October 10, 2014, via FedEx next day delivery with signature confirmation to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action required: Examine your inventory and identify any product subject to this communication. A sample of the product labeling for the lot has been enclosed to assist in product code and lot number identification. The enclosure also depicts the supplied label as well as an image of the label with the correct information. If you have any remaining inventory, a copy of this communication can be kept with the units for future medical record documentation purposes. If you have already used some of the product lot, you may amend any patient record(s) based upon the content of this communication. Please complete and return the accompanying Effectiveness Check Form attached to this letter regardless of whether or not you have any remaining units of the affected product lot. If you may have further distributed or transferred this product, please identify the respective organizations and notify them of this product communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter. This product communication is being made with the knowledge of the Food and Drug Administration. We apologize for any inconvenience this may have caused your organization. Please contact the Davol Customer Service Department at 1-800-556-6275 or C.R. Bard Medical Services & Support Department at 1-800-562-0027 if you have any questions.
Quantity in commerce: 78 units
Distribution: US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.
Product codes and lots: Lot# HUYD0176

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0191-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0191-2015	Class II	Terminated	Voluntary: Firm initiated	2014-11-19	2014-11-07

Product code FTL

K092032Class IIBard Perfix Light Plug, Models 0117050, 0117060, 0117070, 0117080, 0117150, 0117160Davol Inc., Sub. C. R. Bard, Inc. / cleared 2009-12-08

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)