FDA Recall
Terminated
Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length
Recall: Z-0590-03
·
Initiated August 22, 2002
Recall
- Recall Number
- Z-0590-03
- Event Number
- 25502
- Firm
- Symbiosis Corp.
- FEI Number
- 1051710
- Product Code
- DQX
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 22, 2002
- Posted
- February 27, 2003
- Terminated
- July 13, 2012
- Address
- 8600 NW 41th Street, Miami, FL, 33166
Description
Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length
Reason
Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm
Action
Recall letters with response forms were sent to hosptials via FED EX on 8/22/02. Product was to be returned to Boston Scientific in Quincy, MA.
Distribution
Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.
Quantity
27/5 pack boxes