FDA Medical devices recall ·
PERIFIX FX Continuous Epidural Anesthesia Set… recall
- Recall number
- Z-0121-2026
- Date
- (initiated September 18, 2025)
- Company / brand
- B Braun Medical Inc
861 Marcon Blvd, Allentown, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 0 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for the lid of the catheter connector to be in the incorrect position.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF: 332238; Product Code: CE17TFC; UDI-DI (Primary): 04046964178603; UDI-DI (Unit of Use): 04046964178597; Lot Number: 0062014626. Expiration Date: 05/31/2028.
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.
States: Alaska Alabama Arkansas Arizona California Colorado Florida Georgia Hawaii Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina Nebraska New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0121-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.