Product is a ChoICE 182 cm Guide Wire, intended to facilitate placement of balloon dilatation catheters and other therapeutic devices during Percutaneous Transluminal Coronary Angioplasty (PTCA) procedures. The ChoICE guide wire contains a one-piece stainless steel core, which extends throughout the length of the wire and provides steerability and torqueability. The wire is tapered and formed at the distal tip. A radiopaque platinum spring coil surrounds the distal tip of the core wire. The ChoICE Guide Wire is 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. One side of the pouch is clear polyethylene/polyester laminate and the reverse side is Tyvek. The pouch assemblies are packaged in a five-pack product box. A flushing tool is included in the package to facilitate hydration of the coating with heparanized saline before use. 1, page 1, is a copy of the pouch label. Exhibit 1, page 2 is a copy of the five-pack product box label. Exhibit 2 is a copy of the Directions for Use.
FDA Recall Z-0592-03 · Posted 2003-02-27
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Recalling FirmSymbiosis Corp.
Recall StatusTerminated
Product CodeDQX
Date Initiated2002-11-19
Date Terminated2008-04-15
Product Quantity19/5-pack units
Reason for Recall
Product is mislabled as a ChoICE Floppy Guide Wire when it is actually a ChoICE ES(Extra Support) Guide Wire.
Firm Action
Recall Letters issued 11/19/2002 via Federal Express to 7 hospital accounts. Consignees were requested to fill out a response form and return product to their Quincy, MA facility.
Root Cause
Other
Distribution Pattern
Product was distributed to hospitals in FL, MI, GA, OR, ID AND CT. 05.
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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