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Recall Observatory FDA recall evidence

Device product

ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. Product Description: ES1725KFX ESPOCAN SPINAL/EPID. TRAY.

Z-0122-2026

September 18, 2025

Class II

Product summary

Firm
B BRAUN MEDICAL INC
Event
Event 97550
Status
Ongoing
Classification
Class II
Quantity
10,130 units
Official record key
device-enforcement:Z-0122-2026

Official wording

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

Code information: REF: 333196; Product Code: ES1725KFX; UDI-DI (Primary): 04046955899531; UDI-DI (Unit of Use): 04046955899548; Lot Numbers: 0062005817, 0062011662, 0062011663, 0062014354, 0062011664. 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.