Z-2022-2014Class II

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

Name: Z-2022-2014 STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Creator: B. Braun Medical, Inc.
Published: 2014-05-29
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2014-05-29 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches on 2014-05-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2022-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-29
Posted: 2014-07-09
Terminated: 2014-12-10
Recalling firm: B Braun Medical Inc
Product: STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
Product code: FPA Set, Administration, Intravascular
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An urgent medical device correction notification, dated June 3, 2014, describing the product, problem, and actions to be taken, was sent to end users and distributors.
Quantity in commerce: 10,835
Distribution: USA (nationwide) including the states of PA, IL, NC, FL, IL, CA, CO, NE, LA, NC, LA, VA, TN, NE, TX, and KS.
Product codes and lots: Product codes: 473547 and 473549 lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and 61367665, 3/31/2019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2022-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2022-2014	Class II	Terminated	Voluntary: Firm initiated	2014-07-16	2014-07-08

Product code FPA

K942988Class IIFiltered Extension SetsB. Braun of America, Inc. / cleared 1995-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)