Class 3 Device Recall ChoICE PT "J" Tip 182 cm guide Wire

• Date Initiated by Firm: July 16, 2002
• Date Posted: February 27, 2003
• Recall Status: Terminated on April 15, 2008
• Recall Number: Z-0589-03
• Recall Event ID: 25500
• 510(K)Number: K962572
• Product Classification: Wire, Guide, Catheter - Product Code DQX
• Product: 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.
• Code Information: Pouch codes are:Catalog No. 12160-01J, UPN H7491216001J1, batch 4536936, expiration date of 2004-01. The five pack box codes are: Catalog No. 12160-01J, UPN H7491216001J2, batch 4562262, expiration date 2004-01.
• Recalling Firm/ Manufacturer: Symbiosis Corp.; 8600 NW 41th Street; Miami FL 33166
• Manufacturer Reason for Recall: Labeled as J tip but may be straight tip.
• FDA Determined Cause: Other
• 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.
• Quantity in Commerce: 24 units
• Distribution: Product was distributed to 7 hospital accounts in FL, KS, NH, IA, PA, MI AND CA.
• 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