Epidural fixed trays recalled over catheter connector lid position defect
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TKFCPS, 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. closed tip PERIFIX FX springwound epidural catheter, product code CE17TKFCPS, are being recalled because of the potential for the lid of the catheter connector to be in the incorrect position.
The affected product is REF 332078, carrying primary UDI-DI 04046955899432 and unit-of-use UDI-DI 04046955899449. The enforcement record lists the quantity as 0 units. 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 with PERIFIX 17 Ga. x 3-1/2 in. (8.9cm) Tuohy Epidural Needle - Winged and 19 Ga. Closed tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFCPS. Product Description: CE17TKFCPS EPIDURAL FULL TRAY.
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Medical Device — Anesthesia tray
- Hazard
- component-defect
- connector-position
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 (7)
- REF: 332078
- Product Code: CE17TKFCPS
- UDI-DI (Primary): 04046955899432
- UDI-DI (Unit of Use): 04046955899449
- Lot Numbers: 0062006314
- 0062011670
- 0062028428. Expiration Date: 07/31/2026
Distribution
Distributed nationwide across the United States.
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