Continuous epidural anesthesia sets recalled over catheter connector lid position
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Sets, product code CE17TFC, 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 Sets with a PERIFIX Tuohy epidural needle, 17 Ga. x 3-1/2 in. winged, and a PERIFIX FX springwound 19 Ga. closed tip epidural catheter, product code CE17TFC, 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 332238, carrying primary UDI-DI 04046964178603 and unit-of-use UDI-DI 04046964178597. 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 Set, PERIFIX Tuohy Epidural Needle - 17 Ga. x 3-1/2 in. (8.9 cm) - Winged, PERIFIX FX Springwound Epidural Catheter - 19 Ga. Closed tip. Product Code: CE17TFC. Product Description: CE17TFC CONTINUOUS EPID SET W/17G TUOHY.
- Manufacturer
- B BRAUN MEDICAL INC
- Category
- Medical Device — Anesthesia tray
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 (5)
- REF: 332238
- Product Code: CE17TFC
- UDI-DI (Primary): 04046964178603
- UDI-DI (Unit of Use): 04046964178597
- Lot Number: 0062014626. Expiration Date: 05/31/2028.
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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