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Device, Intravascular Catheter Securement

FDA product code KMK · Class 1 · General Hospital

739
Registered devices
749
Adverse events
7
Recalls
64
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2017-04-25Bard Access Systems Inc.StatLockTM IV Premium Catheter Stabilization Device may contain an incorrectly sized retainer clip.
2016-12-09Bard Access SystemsBard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released witho
2016-12-09Bard Access SystemsBard Access Systems announces a voluntary field action for the StatLock Catheter Stabilization Devices because some single unit pouches have been released witho
2013-06-10Bard Access SystemsBARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilization Butterfly Devices due to incorrect pad assembly used during manufacture. The abs
2007-02-15Merit Medical Systems, IncSterility of some units may be compromised due to damaged packaging.
2007-02-15Merit Medical Systems, IncSterility of some units may be compromised due to damaged packaging.
2007-02-15Merit Medical Systems, IncSterility of some units may be compromised due to damaged packaging.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.