Device Recall PT Graphix Intermediate PTCA Guide Wire

  • Model / Serial
    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 ''
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.
  • Product Description
    Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    Symbiosis Corp., 8600 NW 41th Street, Miami FL 33166
  • Source
    USFDA