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Terminated

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

FDA Recall Z-1557-2015 · Posted 2015-04-30

Recalling FirmVital Signs Colorado Inc.
Recall StatusTerminated
Product CodeBSR
Date Initiated2015-03-13
Date Terminated2015-10-07
Product Quantity399

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.

Firm Action

Customers were notified on 3/13/15 via letter to perform an inventory, complete and return the Recall Response Form within 15 days, and to destroy the product on site (do not return to CareFusion).

Root Cause

Packaging

Distribution Pattern

Worldwide Distribution. US Nationwide, Australia, Canada, Chile, Colombia, Dominican Republic, Ecuador, Egypt, Germany, Guatemala, Hong Kong, India, Israel, Italy, Japan, South Korea, Lebanon, Mexico, Netherlands, New Zealand, Panama, Peru, Poland, Russia, Slovenia, Turkey, United Kingdom, and Qatar.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K944729STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCECoast Medical, Inc. · 1994-12-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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