Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.

FDA Recall Z-2455-2008 · Posted 2008-09-21

Recalling FirmVital Signs Colorado Inc.
Recall StatusTerminated
Product CodeBSR
Date Initiated2008-08-11
Date Terminated2011-01-10
Product Quantity73 pieces

Reason for Recall

Light protector may detach from lighted stylet during intubation.

Firm Action

Consignees were notified by letter on 08/11/2008, and instructed to return any unopened and sealed product for replacement.

Root Cause

Device Design

Distribution Pattern

Worldwide including states of CA, OH, MD, NC, TX and VA facilities in GA, IN, MS, NC, NJ, NM, NY, and VA. Foreign distribution to Argentina, Australia, Canada, Chile, China, Colombia, Dominican Republic, Dubai, Ecuador, Egypt, Germany, Hong Kong, India, Indonesia, Israel, Italy, Korea, Malaysia, Mexico, Nepal, Netherlands, New Zealand, Philippines, Qatar, Republic of China, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Thailand, UK, and Venezuela.

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.

↑