Customer Epidural Anesthesia Tray — Class II medical device recall Z-0574-2018
Terminated recall by B. Braun Medical, Inc., reported 2018-02-21, distributed nationwide. B. Braun Medical Inc. (BBMI) initiated this recall of various BBMI convenience kits containing the 22GA 1-1/2i
| Recall number | Z-0574-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | B. Braun Medical, Inc., Allentown, PA, United States |
| Recall initiated | 2017-06-21 |
| Classified | 2018-02-09 |
| Reported by FDA | 2018-02-21 |
| Terminated | 2018-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 120 units |
| Reason classes | foreign material |
| Model numbers | 555234 |
Product
Customer Epidural Anesthesia Tray. Product Catalog Number: 555234. Local anesthesia of the skin prior to insertion of the regional anesthesia needle.
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 to the 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0574-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.