CLASS II ONGOING Device recall · Reported 15 Oct 2025 · FDA Enforcement Report

Ce17tbfc Epidural Basic Tray Touhy recalled by B Braun Medical

B Braun Medical is recalling Ce17tbfc Epidural Basic Tray Touhy, distributed nationwide in the US. The recall was initiated on 18 Sep 2025 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesREF: 332077; Product Code: CE17TBFC; UDI-DI (Primary): 4046964177187; UDI-DI (Unit of Use): 4046964177170; Lot Number: 0062022053. Expiration Date: 10/16/2024

Quantity recalled0 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0114-2026
FDA event ID: 97550
Recalling firm: B Braun Medical, Allentown, PA
Classification: Class II
Status: Ongoing
Recall initiated: 18 Sep 2025
FDA classified: 9 Oct 2025
Reported: 15 Oct 2025
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

18 Sep 2025	Recall initiated by company
9 Oct 2025	Classified by FDA	+21 days
15 Oct 2025	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in. (9cm) Tuohy Epidural Needle - Winged and PERIFIX FX Springwound Catheter - 19 Ga. Closed Tip. Product Code: CE17TBFC. Product description: CE17TBFC EPIDURAL BASIC TRAY 17G TOUHY.

Where it was distributed

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.

Nationwide Alaska Alabama Arkansas Arizona California Colorado Florida Georgia Hawaii Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri

Questions about this recall

Is Ce17tbfc Epidural Basic Tray Touhy recalled?

Yes. B Braun Medical recalled Ce17tbfc Epidural Basic Tray Touhy on 18 Sep 2025. The recall is Class II and its status is Ongoing. Recall number Z-0114-2026.

Why was it recalled?

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

Which lots are affected?

REF: 332077; Product Code: CE17TBFC; UDI-DI (Primary): 4046964177187; UDI-DI (Unit of Use): 4046964177170; Lot Number: 0062022053. Expiration Date: 10/16/2024

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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