CLASS II Device recall · Reported 19 Nov 2014 · FDA Enforcement Report
Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is recalled
Davol, Inc., Subs. C. R. Bard is recalling Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if, distributed in 8 states. The recall was initiated on 8 Oct 2014 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0191-2015
- FDA event ID
- 69464
- Recalling firm
- Davol, Inc., Subs. C. R. Bard, Warwick, RI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Oct 2014
- FDA classified
- 7 Nov 2014
- Reported
- 19 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 8 Oct 2014 | Recall initiated by company | |
| 7 Nov 2014 | Classified by FDA | +30 days |
| 19 Nov 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.
CaliforniaDelawareMarylandMinnesotaMissouriNew MexicoOhioUtah
Questions about this recall
Is Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if recalled?
Yes. Davol, Inc., Subs. C. R. Bard recalled Bard¿ PerFix Light Plug The Bard¿ PerFix Light Plug is indicated for reinforcement if on 8 Oct 2014. The recall is Class II and its status is Terminated. Recall number Z-0191-2015.
Why was it recalled?
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.
Which lots are affected?
Lot# HUYD0176
Where was it sold?
US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Davol, Inc., Subs. C. R. Bard
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Bard¿ Ventralight" ST Mesh with Echo PS TM 7"x9" recalled | Davol, Inc., Subs. C. R. Bard | Sterility | Nationwide |
| Device | CLASS II | Bard¿ Ventralight" ST Mesh with Echo PS" 5" Circle recalled | Davol, Inc., Subs. C. R. Bard | Sterility | Nationwide |
| Device | CLASS II | Bard¿ Ventralight" ST Mesh with Echo PS" 8" Circle Number recalled | Davol, Inc., Subs. C. R. Bard | Sterility | Nationwide |
| Device | CLASS II | Bard¿ Ventralight" ST Mesh recalled by Davol, Inc., Subs. C. R. Bard | Davol, Inc., Subs. C. R. Bard | Sterility | Nationwide |
| Device | CLASS II | Bard¿ Ventralight" ST Mesh with Echo PS" 6"x8" recalled | Davol, Inc., Subs. C. R. Bard | Sterility | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |