FDA Device recall Z-0118-2026
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX…
- FDA Device
- Class II
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class II recall of PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX… by B Braun Medical, citing potential for the lid of the catheter connector to be in the incorrect position.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0118-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-09-18 |
| Published | 2025-10-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | B Braun Medical |
| Distribution | US |
Product
PERIFIX FX Continuous Epidural Anesthesia Tray, 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Fixed Wings, 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFSDT. Product Description: CE17TKFSDT EPID TRAY W/17GA FIXED WING.
Reason
Potential for the lid of the catheter connector to be in the incorrect position.
Identifiers
| code_info | REF: 332093; Product Code: CE17TKFSDT; UDI-DI (Primary): 04046964954252; UDI-DI (Unit of Use): 04046964954245; Lot Numb…REF: 332093; Product Code: CE17TKFSDT; UDI-DI (Primary): 04046964954252; UDI-DI (Unit of Use): 04046964954245; Lot Number: 0062003112. Expiration Date: 07/31/2026. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0118-2026%22
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