CLASS II Device recall · Reported 21 Feb 2018 · FDA Enforcement Report
Perifix Continuous Epidural Anesthesia Tray recalled by B. Braun Medical
B. Braun Medical is recalling Perifix Continuous Epidural Anesthesia Tray, distributed nationwide in the US. The recall was initiated on 21 Jun 2017 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-0567-2018
- FDA event ID
- 78878
- Recalling firm
- B. Braun Medical, Allentown, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Jun 2017
- FDA classified
- 9 Feb 2018
- Reported
- 21 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Syringes & Needles
Timeline
| 21 Jun 2017 | Recall initiated by company | |
| 9 Feb 2018 | Classified by FDA | +233 days |
| 21 Feb 2018 | 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
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Where it was distributed
US Nationwide Distribution.
Questions about this recall
Is Perifix Continuous Epidural Anesthesia Tray recalled?
Yes. B. Braun Medical recalled Perifix Continuous Epidural Anesthesia Tray on 21 Jun 2017. The recall is Class II and its status is Terminated. Recall number Z-0567-2018.
Why was it recalled?
B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2in SafetyGlide Needle due tothe presence of loose polypropylene foreign matter was above release specification. This foreign matter has been identified as a product hub material which has been tested for biocompatibility per ISO 10993 during the product development process.
Which lots are affected?
0061482555. 0061515153. 0061518685. 0061520983. 0061520983. 0061528975. 0061547818. 0061486692. 0061518681. 0061523687. 0061529146. 0061539137. 0061546529.
Where was it sold?
US Nationwide Distribution.
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.
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