FDA-Device2025-10-15Class II

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.

Hazard

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

Sold states
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.
Affected count
0 units
Manufactured in
861 Marcon Blvd, Allentown, PA, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0121-2026

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