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Recall Observatory FDA recall evidence

Device product

PERIFIX FX Continuous Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle - Winged and 19 Ga. Open tip PERIFIX FX Springwound Epidural Catheter. Product Code: CE17TKFS. Product Description: CE17TKFS EPIDURAL TRAY.

Z-0120-2026

September 18, 2025

Class II

Product summary

Firm
B BRAUN MEDICAL INC
Event
Event 97550
Status
Ongoing
Classification
Class II
Quantity
2,760 units
Official record key
device-enforcement:Z-0120-2026

Official wording

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

Code information: REF: 332098; Product Code: CE17TKFS; UDI-DI (Primary): 04046955901067; UDI-DI (Unit of Use): 04046955901074; Lot Numbers: 0062009622, 0062014350. Expiration Date: 07/31/2026.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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