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Recall Observatory FDA recall evidence

Device product

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

Z-2022-2014

May 29, 2014

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 68546
Status
Terminated
Classification
Class II
Quantity
10,835
Official record key
device-enforcement:Z-2022-2014

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.