FDA Medical Device Recalls (openFDA)
Davol, Inc., Subs. C. R. Bard, Inc.: 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.
- Recall number
- Z-0191-2015
- Recalling firm
- Davol, Inc., Subs. 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.
- Status
- Terminated
- Initiated
- 2014-10-08
- Posted
- 2014-11-07
- Terminated
- 2015-12-23
- Reason
- 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
- 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
- 78 units
- Distribution
- US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.
- Lot, serial or model codes
- Lot# HUYD0176
- 510(k) numbers
- ["K092032"]
- PMA numbers
- not on file
- Product code
- FTL
- Firm FEI
- 1213643
- Firm city
- Warwick
- Firm state
- RI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28