Vital Signs Intubation Pack, Part Number: INTPKF, Sterile, Vital Signs Colorado Inc, Englewood, CO 80112. Contains one lighted stylet per pack.
This recall has been terminated (originally issued September 21, 2008).
- Company
- Vital Signs Colorado Inc.
- Recall Initiated
- August 11, 2008
- Posted
- September 21, 2008
- Terminated
- January 10, 2011
- Recall Number
- Z-2455-2008
- Quantity
- 73 pieces
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Light protector may detach from lighted stylet during intubation.
Distribution
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.
Lot / Code Info
Lot numbers: X144, X172, X217, X273, X299, X300, X307, X333, X350, 052A, 081A, 093A, 166A, 271A, 319A, 349A, 033D, 101D, 116D, 164D, 219D, 233D, 291D, 346D, 004F, 058F, 063F, 197F.
Root Cause
Device Design
Action Taken
Consignees were notified by letter on 08/11/2008, and instructed to return any unopened and sealed product for replacement.