PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080
This recall has been terminated (originally issued July 20, 2004).
- Company
- Smiths Medical Asd, Inc.
- Recall Initiated
- December 12, 2003
- Posted
- July 20, 2004
- Terminated
- May 2, 2006
- Recall Number
- Z-0569-04
- Quantity
- 30 CASES (2/CASE)
- Firm Location
- Keene, NH
- Official Source
- View on FDA website ↗
Reason for Recall
Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm
Distribution
AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI
Lot / Code Info
Lot Number: K223373
Root Cause
Other
Action Taken
Smiths Medical contacted dealers via telephone on December 12, 2003. The direct customers to whom product was shipped contacted via a visit by the Smiths Medical sales representative Monday, December 15, 2003 through December 12,2 003.
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