FDA Medical Device Recalls (openFDA)
B. Braun Medical, Inc.: STOPCOCK EXT. SET W/ 3-WAY STOPCOCK WITH INJ. SITE AND SPINLOCK CONNECTOR, 22 inches and 37 inches
- Recall number
- Z-2022-2014
- 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
- Status
- Terminated
- Initiated
- 2014-05-29
- Posted
- 2014-07-09
- Terminated
- 2014-12-10
- 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.
- 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
- 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.
- Lot, serial or model codes
- Product codes: 473547 and 473549 lot #s and expiration dates: 61356774, 1/31/2019; 61362114, 2/28/2019; and 61367665, 3/31/2019.
- 510(k) numbers
- ["K942988"]
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28