CLASS II Device recall · Reported 11 Sep 2019 · FDA Enforcement Report

Ce17tkn Cont Epiduraltuohy Nrfit recalled by B. Braun Medical

B. Braun Medical is recalling Ce17tkn Cont Epiduraltuohy Nrfit, distributed in 10 states. The recall was initiated on 10 Jul 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 0061536635 Exp: 10/31/2018 Lot # 0061620271 Exp:11/30/2019 UDI: 04046964941337

Quantity recalled540 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-2469-2019
FDA event ID: 83478
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Terminated
Recall initiated: 10 Jul 2019
FDA classified: 5 Sep 2019
Reported: 11 Sep 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

10 Jul 2019	Recall initiated by company
5 Sep 2019	Classified by FDA	+57 days
11 Sep 2019	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

The filter capacity is not achieved due to damage of the filter membrane.

Product as listed by the FDA

CE17TKN CONT EPIDURALTUOHY NRFIT Catalog # 339183

Where it was distributed

CA FL MO TX MN AL GA NC IL PA

Alabama California Florida Georgia Illinois Minnesota Missouri North Carolina Pennsylvania Texas

Questions about this recall

Why was it recalled?

The filter capacity is not achieved due to damage of the filter membrane.

Which lots are affected?

Lot # 0061536635 Exp: 10/31/2018 Lot # 0061620271 Exp:11/30/2019 UDI: 04046964941337

Where was it sold?

CA FL MO TX MN AL GA NC IL PA

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.

Other products in this recall event

8 other products · FDA event 83478

This product is part of a recall event; the main page for the event is Ce17tkfcn Epid Tray W/ Tuohy Nrfit recalled by B. Braun Medical.

Reported	Class	Recall	Company	Reason	Where
11 Sep 2019	CLASS II	Ce17tkfcn Epid Tray W/ Tuohy Nrfit recalled by B. Braun Medical	B. Braun Medical	Other	10 states
11 Sep 2019	CLASS II	Es1725kfxn Espocan Spinal/epid Try Nrfit recalled by B. Braun Medical	B. Braun Medical	Other	10 states
11 Sep 2019	CLASS II	Ce17tkfcsn Con Epi Tray W/ Tuhy Nrfit recalled by B. Braun Medical	B. Braun Medical	Other	10 states
11 Sep 2019	CLASS II	Ce18tkstn Cont Epid W/soft Tip Nrfit recalled by B. Braun Medical	B. Braun Medical	Other	10 states
11 Sep 2019	CLASS II	Ce18tkn Accu-bloc Perifix Kit Nrfit recalled by B. Braun Medical	B. Braun Medical	Other	10 states
11 Sep 2019	CLASS II	Ce18hkn Accu-bloc Perifix Kit Nrfit recalled by B. Braun Medical	B. Braun Medical	Other	10 states
11 Sep 2019	CLASS II	Fef 100n Flat Epidural Filter Nrfit recalled by B. Braun Medical	B. Braun Medical	Other	10 states
11 Sep 2019	CLASS II	Es1827kn Spinal/epidural Tray Nrfit recalled by B. Braun Medical	B. Braun Medical	Other	10 states

More recalls from B. Braun Medical

All 447

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10 Jun 2026Device	CLASS I	Design Options Spinal Tray Spinal Needle Anesthesia recalled	B Braun Medical	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS II	Sesk Upmc Double Catheter Tray recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide

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