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Devices
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
Cardiovascular Devices
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
Symbiosis Corp.
1 Event
Recall of Device Recall PT Graphix Intermediate PTCA Guide Wire
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Manufacturer
Symbiosis Corp.
Manufacturer Address
Symbiosis Corp., 8600 NW 41th Street, Miami FL 33166
Source
USFDA
Language
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