Recall Z-1557-2015— Vital Signs Colorado Inc.

Name: FDA recall Z-1557-2015
Creator: U.S. Food and Drug Administration
Published: 2015-03-13

Class II · Terminated

Class II FDA medical device recall by Vital Signs Colorado Inc., initiated 2015-03-13, terminated 2015-10-07. It names one FDA 510(k) clearance: K944729. Product: Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.. Reason: 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..

Recalling firm: Vital Signs Colorado Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-03-13
Terminated: 2015-10-07
Firm location: Englewood, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K944729 — STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCECoast Medical, Inc.·cleared 1994-12-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Introduction Pack. A device inserted into an endotracheal tube to aid in the intubation procedure.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.