Scimed PT Graphix Intermediate PCTA Guide Wire with ICE Hydrophilic Coating, 300 cm length.
FDA Recall Z-0591-03 · Posted 2003-02-27
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Recalling FirmSymbiosis Corp.
Recall StatusTerminated
Product CodeDQX
Date Initiated2002-08-22
Date Terminated2012-07-13
Product Quantity228/5 pack boxes
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
Firm 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.
Root Cause
Other
Distribution Pattern
Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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