FDA Device recall Z-0567-2018
Perifix Continuous Epidural Anesthesia Tray
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Perifix Continuous Epidural Anesthesia Tray by B Braun Medical, citing 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 foreig….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0567-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-06-21 |
| Published | 2018-02-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
Perifix Continuous Epidural Anesthesia Tray. Product Catalog Numbers: 332075, 332266. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
Reason
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.
Identifiers
| code_info | 0061482555. 0061515153. 0061518685. 0061520983. 0061520983. 0061528975. 0061547818. 0061486692. 0061518681. 00…0061482555. 0061515153. 0061518685. 0061520983. 0061520983. 0061528975. 0061547818. 0061486692. 0061518681. 0061523687. 0061529146. 0061539137. 0061546529. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0567-2018%22
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