Stylet Sheath with Locking Cap and Reusable Battery Operated Light Source

• 2 recalls, same reason

  • Terminated Z-1556-2015 FDA Class II ·initiated 13 Mar 2015
  • Terminated Z-1557-2015 FDA Class II ·initiated 13 Mar 2015

  Vital Signs Colorado (dba CareFusion) is recalling Vital Signs LightWand Stylet catalog numbers 3910 and 3960 due to a potential patient safety risk involving a breach in the sterile packaging that may not be recognized prior to use.

• 3 recalls, same reason

  • Terminated Z-2454-2008 FDA Unclassified (pre-2012) ·initiated 11 Aug 2008
  • Terminated Z-2455-2008 FDA Unclassified (pre-2012) ·initiated 11 Aug 2008
  • Terminated Z-2456-2008 FDA Unclassified (pre-2012) ·initiated 11 Aug 2008

  Light protector may detach from lighted stylet during intubation.

510(k) Number

K944729 ↗

FDA Product Code

BSR

Device Class

Class I

Regulation

21 CFR Part 868.5790

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Surface Temperature Probes

  Class II

  FDA 510(k) K943270 Active Cleared 5 Dec 1994

• Disposable Uncuffed Endotracheal Tube

  Class II

  FDA 510(k) K925855 Active Cleared 18 Feb 1993

• Coast Medical, Inc. Rectal Probe

  Class II

  FDA 510(k) K930930 Active Cleared 25 Feb 1994

• Extension Set/I.V. Set

  Class II

  FDA 510(k) K952243 Active Cleared 26 Jul 1995

• Disposable Cuffed Endotracheal Tube

  Class II

  FDA 510(k) K925781 Active Cleared 19 Apr 1993

• Disposable Intubation Kits

  Class II

  FDA 510(k) K921077 Active Cleared 25 Aug 1992

See all devices from Coast Medical Corp. →