Scimed ChoICE PT ''J'' Tip 182 cm Guide Wire, a single use, sterile (EO), device packaged in a carrier tube, which is held in a coil by plastic clips. The carrier tube assembly of the guide wire is sealed into a pouch. The pouch assembies are packaged in a five-pack product box.
FDA Recall Z-0589-03 · Posted 2003-02-27
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Recalling FirmSymbiosis Corp.
Recall StatusTerminated
Product CodeDQX
Date Initiated2002-07-16
Date Terminated2008-04-15
Product Quantity24 units
Reason for Recall
Labeled as J tip but may be straight tip.
Firm Action
The firm notified all user/hospital accounts via a 7/16/2002 letter sent via FEDEX along with a response form. Accounts were to return any recalled product.
Root Cause
Other
Distribution Pattern
Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA.
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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