PERIFIX FX Epidural Anesthesia Tray Catheter Connector Lid Position Defect
B Braun is recalling PERIFIX FX Epidural Anesthesia Trays due to a defect where the catheter connector lid may be in an incorrect position. This could affect proper anesthetic delivery.
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: FDA Class II medical device with a mechanical defect affecting the catheter connector. No injuries, illnesses, or adverse events have been reported. The recall is precautionary for a potential manufacturing defect.
Plain-English summary
B Braun Medical Inc is recalling PERIFIX FX Continuous Epidural Anesthesia Trays (product code CE17TBFC). Each tray includes a 17-gauge Tuohy epidural needle and 19-gauge springwound catheter intended for use in epidural anesthesia procedures.
The recall is due to a potential defect where the lid of the catheter connector may be in an incorrect position. This malfunction could affect proper operation of the anesthesia delivery system.
The affected units have lot number 0062022053 with an expiration date of 10/16/2024. The product was distributed nationwide to medical facilities across all U.S. states and territories.
Healthcare facilities that received this product should verify their inventory using the lot number and expiration date. Facilities with affected units should contact B Braun Medical Inc or their medical device distributor regarding the recall.
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
- Hazard
- connector-defect
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
Distributed nationwide across the United States.
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