FDA Device recall Z-0569-2018
Pencan Spinal Needle Tray
- FDA Device
- Class II
- terminated
- Published 2018-02-21
On 2018-02-21 the FDA classified a Class II recall of Pencan Spinal Needle 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 to the presence of loose polypropylene forei….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0569-2018 |
| 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
Pencan Spinal Needle Tray. Product Catalog Number: 333865. 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 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.
Identifiers
| code_info | 0061483775. 0061486469. 0061519983. 0061525310. 0061529050. 0061531352. 0061535252. 0061540004. |
|---|
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-0569-2018%22
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