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U.S. Department of Health and Human Services

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

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  Class 3 Device Recall Scimed ChoIce Floppy PTCA Guide Wire 182 cm see related information
Date Initiated by Firm November 19, 2002
Date Posted February 27, 2003
Recall Status1 Terminated 3 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/
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 2
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.