Scimed PT Graphix Intermediate PCTA 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-0591-03
- Quantity
- 228/5 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 as follows: Catalog No. 14914-01 UPN H74914914011 Lot Number Expiration Date 4772607 2004-0 4772610 '' 4762379 '' 4762384 '' 4772618 '' 4766619 '' 4758393 '' 4758432 '' 4753775 '' 4758389 '' 4758427 '' 4756521 '' 4762390 '' 4756485 '' 4753781 '' 4758397 '' 4758423 '' 4753783 '' 4753785 '' 4740328 2004-4 4753779 2004-5 4753759 '' 4753769 '' 4756534 '' 4756536 '' 4756531 '' 4724690 2004-4 4740329 '' 4736552 '' The above PT Graphix¿ guide wire pouch lots were packaged in 18 lots of five-pack boxes with the following codes: Catalog No. 1215T UPN H74914914012 Lot Number Expiration Date 4789558 2004-05 4791600 '' 4789558 '' 4791126 '' 4785009 '' 4787988 '' 4786427 '' 4783177 '' 4780051 '' 4780186 '' 4783316 '' 4780190 '' 4782079 '' 4780939 '' 4771889 '' 4777410 '' 4775761 '' 4776272 '' 4766792 ''
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.