Open tip epidural trays recalled over catheter connector lid position
B. Braun is recalling 2,760 PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TKFS, because the lid of the catheter connector may be in the incorrect position.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 because the record describes a component position defect without stating a hazard, clinical consequence or reported harm.
Plain-English summary
PERIFIX FX Continuous Epidural Anesthesia Trays with a PERIFIX 17 Ga. x 3-1/2 in. winged Tuohy epidural needle and a 19 Ga. open tip PERIFIX FX springwound epidural catheter, product code CE17TKFS, are being recalled because of the potential for the lid of the catheter connector to be in the incorrect position.
The recall covers 2,760 units, REF 332098, carrying primary UDI-DI 04046955901067 and unit-of-use UDI-DI 04046955901074. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record describes the connector lid position and does not state any injury or clinical consequence. Facilities should check affected lots and follow B. Braun's instructions.
The recalled product
- Product
- PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Medical Device — Anesthesia tray
- Affected units
- 2,760
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- REF: 332098
- Product Code: CE17TKFS
- UDI-DI (Primary): 04046955901067
- UDI-DI (Unit of Use): 04046955901074
- Lot Numbers: 0062009622
- 0062014350. Expiration Date: 07/31/2026.
Distribution
Part of a larger recall action
This product is one of 13 recalled by B BRAUN MEDICAL INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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