Class 3 Device Recall Scimed ChoIce Floppy PTCA Guide Wire 182 cm

• Date Initiated by Firm: November 19, 2002
• Date Posted: February 27, 2003
• Recall Status: Terminated on April 15, 2008
• Recall Number: Z-0592-03
• Recall Event ID: 25512
• 510(K)Number: K962572
• Product Classification: Wire, Guide, Catheter - Product Code DQX
• Product: 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.
• Code Information: Individual pouch codes are coded catalog # 12132-01, batch 4785750 expiration date 2004-05 and the five pack outer boxes are coded: Catalog No. 12132-01, batch 4806821 expiration date 2004-5.
• Recalling Firm/ Manufacturer: Symbiosis Corp.; 8600 NW 41th Street; Miami FL 33166
• Manufacturer Reason for Recall: Product is mislabled as a ChoICE Floppy Guide Wire when it is actually a ChoICE ES(Extra Support) Guide Wire.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 19/5-pack units
• Distribution: Product was distributed to hospitals in FL, MI, GA, OR, ID AND CT. 05.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = DQX and Original Applicant = SCIMED LIFE SYSTEMS, INC.