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Z-0121-2026Class II

B BRAUN MEDICAL INC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
B BRAUN MEDICAL INC
Product type
Device
Status
Ongoing
Report date
2025-10-15
Distribution
Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.
Firm state
PA
Product quantity
0 units
Initiated by
Voluntary: Firm initiated
Reason for recall

Potential for the lid of the catheter connector to be in the incorrect position.

Product description

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.

Code / lot info

REF: 332238; Product Code: CE17TFC; UDI-DI (Primary): 04046964178603; UDI-DI (Unit of Use): 04046964178597; Lot Number: 0062014626. Expiration Date: 05/31/2028.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →