Epidural basic trays recalled over catheter connector lid position defect
B. Braun is recalling PERIFIX FX Continuous Epidural Anesthesia Trays, product code CE17TBFC, 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. Tuohy epidural needle and a PERIFIX FX springwound 19 Ga. closed tip catheter, product code CE17TBFC, 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 332077, carrying primary UDI-DI 4046964177187 and unit-of-use UDI-DI 4046964177170. 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. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.
- 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: 332077
- Product Code: CE17TBFC
- UDI-DI (Primary): 4046964177187
- UDI-DI (Unit of Use): 4046964177170
- Lot Number: 0062022053. Expiration Date: 10/16/2024
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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