CLASS II Device recall · Reported 16 Jul 2014 · FDA Enforcement Report

Stopcock EXT recalled by B. Braun Medical

B. Braun Medical is recalling Stopcock EXT, distributed nationwide in the US. The recall was initiated on 29 May 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct codes: 473547 and 473549 lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and 61367665, 3/31/2019.

Quantity recalled10,835

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-2022-2014
FDA event ID: 68546
Recalling firm: B. Braun Medical, Allentown, PA
Classification: Class II
Status: Terminated
Recall initiated: 29 May 2014
FDA classified: 8 Jul 2014
Reported: 16 Jul 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

29 May 2014	Recall initiated by company
8 Jul 2014	Classified by FDA	+40 days
16 Jul 2014	Published in enforcement report	+8 days

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

Reason for recall

Complaints were received that reported the stopcock of some Stopcock Extension Sets are assembled in the reverse position, resulting in the stopcock being closed when set in the open position and vise versa.

Product as listed by the FDA

STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches

Where it was distributed

USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.

Nationwide California Colorado Florida Illinois Kansas Louisiana North Carolina Nebraska Pennsylvania Tennessee Texas Virginia

Questions about this recall

Is Stopcock EXT recalled?

Yes. B. Braun Medical recalled Stopcock EXT on 29 May 2014. The recall is Class II and its status is Terminated. Recall number Z-2022-2014.

Why was it recalled?

Which lots are affected?

Product codes: 473547 and 473549 lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and 61367665, 3/31/2019.

Where was it sold?

USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.

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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