CLASS II Device recall · Reported 10 Oct 2018 · FDA Enforcement Report

CE17TKFC Epidural Tray W/ Tuohy recalled by B. Braun Medical

B. Braun Medical is recalling CE17TKFC Epidural Tray W/ Tuohy, Material Number 332079 Connection device used by, distributed nationwide in the US. The recall was initiated on 20 Jul 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesBatch: 61588411, 61589132, 61590240, 61591302, 61591816, 61592013, 61592513, 61594212, 61595169, 61595496, 61596322, 61596323, 61597455, 61597456, 61618678, 61614704, 61618680, 61618681, 61621829, 61621830, 61587111, 61587112

Quantity recalled69750

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-3333-2018
FDA event ID: 80811
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Terminated
Recall initiated: 20 Jul 2018
FDA classified: 1 Oct 2018
Reported: 10 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

20 Jul 2018	Recall initiated by company
1 Oct 2018	Classified by FDA	+73 days
10 Oct 2018	Published in enforcement report	+9 days

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

Reason for recall

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

CE17TKFC EPIDURAL TRAY W/ 17GA TUOHY, Material Number 332079 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

Where it was distributed

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

Nationwide

Questions about this recall

Why was it recalled?

The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

Which lots are affected?

Batch: 61588411, 61589132, 61590240, 61591302, 61591816, 61592013, 61592513, 61594212, 61595169, 61595496, 61596322, 61596323, 61597455, 61597456, 61618678, 61614704, 61618680, 61618681, 61621829, 61621830, 61587111, 61587112

Where was it sold?

Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

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 26 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

92 other products · FDA event 80811

This product is part of a recall event; the main page for the event is CE17TKFSDTD Epid Tray W/ Fixed Wing recalled by B. Braun Medical.

Reported	Class	Recall	Company	Reason	Where
10 Oct 2018	CLASS II	CE17TKFSDTD Epid Tray W/ Fixed Wing recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CNB200TKU Non-stim Cath Full Kit recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CNBFX350O Contiplex Cont Nerve Block recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TBFC Epidural Basic Tray Touhy recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKPS Continuous Epidural Anes Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKCD Cont Epidural Anesthesia Kit recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Epid Paed Full Kit CT NG Cath LF recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Contiplex Tuohy Ultra Cont recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKFCS Cont Epid Tray W/ Tuohy-lf recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TKCD Cont Epidural Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TBLS Cont Epidural Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Contiplex Tuohy Set, 18GX6", 1.3X150MM recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TKPS Cont Epidural Tray (LF) recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	EC20C Cath Closed, Material Number 333540 Connection device recalled	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	SCNB4TK Cont Stim W/ Insul Tuohy recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Espocan Spinal/Epid Tray W/ Tuohy recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKST Cont Epid W/Soft Tip recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKFCPS Epidural Full Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CCE18HK10L Cont Epidural Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKFSDT Epid Tray W/ Fixed Wing recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKFCY Safety Tuohy Needle Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	ES1827QK Espocan Combined, Material Number recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TKDP Cont Epid/Duraprep recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKCDLS Cont Epidural Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Cep18tko Cont recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TKY Safety Tuohy Needle Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Cont Stim Basic Kit W/ Insul Tuohy recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CNB200TK Contiplex Cont Nerve Block recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	EC20O Cath Open Tip LF, Material Number 333520 Connection recalled	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Ce17tkf Perifix Contin recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Contiplex Tuohy Ultra CNB400TU, LF recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Conti Echo CT W/ Tuohy Ultra 360 Set recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Contiplex Cont Tuohy Ultra Pnb Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	EC20CS Epidural Catheter, Material Number 333532 Connection recalled	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TKCD10L Tuohy/10CC Glas recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18T Cont Epidural Set, Material Number 332200 Connection recalled	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Contiplex Echo OT W/4" Tuohy Ultra Set recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TB Cont Epidural Tuohy, Material Number recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Conti Cont 4inTUOHY Ultra 360 Pnb Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Conti Tuohy Ultra 360 Cont Pnb Set recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	EC19CF Cath Closed Tip LF, Material Number recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18HKCD Cont Epidural Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Design Options¿ Pain Management Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	EC19OF Springwound Epid Catheter recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TK19CDP Cont Epidural Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Ce18hkps Contin recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	GOVCE18TKST Cont Epid W/Soft Tip recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17T Cont Epidural Set, Material Number 332202 Connection recalled	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Es1725kfx Espocan Spinal/epid recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Epid. Cath. NG. Closed Tip-lf recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TB Cont Epidural Tray, Material Number recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Ce17tf Perifix Fx Contin recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Bulk Nonsterile Perifix Catheter Conn. recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TFC Continuous Epid Set W/ Tuohy recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TK Accu-bloc Perifix Kit recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18H Cont Epidural Set, Material Number 332210 Connection recalled	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	ES1725K Spinal/Epidural Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	GOVCE17TKFC Epidural Tray W/ Tuohy recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18HB Cont Epidural Hustead recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	EC20CST Clsd Soft Tip Cath, Material Number recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	NES1727KFX W / Tuohy Sprw OT recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Contiplex Tuohy Set, 18GX4", 1.3X100MM recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TKST Cont Epid W/Soft Tip recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CNB400TKU Non-stim Cath Full Kit recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Clamp Style Catheter Connector- LF recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	EC19C Catheter Closed, Material Number 333511 Connection recalled	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TO Cont Epidural Set LF recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CEP20TO Cont Epid Pediatric Set recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CNB200S Contiplex Insulated Tuohy Ndl recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TIN Cont Epidural Set LF recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	GOVES1827K Spinal/Epidural Tray (LF) recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18HK Accu-bloc Perifix Kit recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CNBFX350C Contiplex Cont Nerve Block recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKFS Epidural Tray, Material Number 332098 Connection recalled	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CNB400TK Contiplex Cont Nerve Block recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Contiplex Tuohy Set, 18GX11/,3X40MM recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Cont Stim Basic Kit W/ Insul Tuohy recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CNB200T Contiplex Tuohy Set recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18HKST Cont Epid Softip, Material Number recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	ES1827K Spinal/Epidural Tray (LF) recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	ES1827KDS Spinal/Epidural Full Kit recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TKO Perifix One Epidural Full Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TK Cont Epiduraltuohy, Material Number recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CNB400TU3KUE 18GX4 Conti Thy Ultra recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKFSA Full Tray W/ Tuohy Sprw recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE18TOD Cont Epidural Tray LF recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Clamp Style Cath recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TOD Cont Epidural Tray LF recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	Ce17tkfps Perifix Fx Cont recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	GOVCE18TK Accu-bloc Perifix Kit recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TKFMHDTFULL EPID KIT, Material Number 332096 Connection recalled	B. Braun Medical	Packaging Defects	Nationwide
10 Oct 2018	CLASS II	CE17TB19C Cont Epidural Tray recalled by B. Braun Medical	B. Braun Medical	Packaging Defects	Nationwide

More recalls from B. Braun Medical

All 447

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Extension Set Discofix Four Way Stopcock recalled by B Braun Medical	B Braun Medical	Other	Nationwide
3 Sep 2026Drug	ANNOUNCED	B. Braun 0.9% Sodium Chloride Injection USP, in a PAB Container recalledB. Braun	B. Braun Medical	Particulate Matter	Nationwide
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
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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All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide