Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length
This recall has been terminated (originally issued February 27, 2003).
- Company
- Symbiosis Corp.
- Recall Initiated
- August 22, 2002
- Posted
- February 27, 2003
- Terminated
- July 13, 2012
- Recall Number
- Z-0590-03
- Quantity
- 27/5 pack boxes
- Firm Location
- Miami, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm
Distribution
Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.
Lot / Code Info
Individual Devices in Pouches with Catalog No. 12155-01, UPN H74912155011, Lot Number 4773987, exp. date 2004-5. These pouches were packaged in two lots of five-pack boxes with the following codes: Catalog 12155-01, lot 4791304 Catalog 12155-01, lot 4798294
Root Cause
Other
Action Taken
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.
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