FDA Device recall Z-0116-2026
PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed ti…
- 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 with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed ti… 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-0116-2026 |
| 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 with PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFC. Product Description: CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY.
Reason
Potential for the lid of the catheter connector to be in the incorrect position.
Identifiers
| code_info | REF: 332079; Product Code: CE17TKFC; UDI-DI (Primary): 04046955899456; UDI-DI (Unit of Use): 04046955899463; Lot Number…REF: 332079; Product Code: CE17TKFC; UDI-DI (Primary): 04046955899456; UDI-DI (Unit of Use): 04046955899463; Lot Numbers: 0062010541, 0062010542, 0062010543, 0062010545, 0062010546, 0062010547, 0062010548, 0062010549, 0062010550, 0062010743, 0062013041, 0062013042, 0062013043, 0062013044, 0062013045, 0062013046, 0062013047, 0062013049, 0062015114, 0062015113, 0062015112, 0062015110. 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-0116-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.