Class 3 Device Recall ChoICE PT Extra Support PTCA Guide Wire

• Date Initiated by Firm: August 22, 2002
• Date Posted: February 27, 2003
• Recall Status: Terminated on July 13, 2012
• Recall Number: Z-0590-03
• Recall Event ID: 25502
• 510(K)Number: K960657
• Product Classification: Wire, Guide, Catheter - Product Code DQX
• Product: Scimed ChoICE PT Extra Support PTCA Guide Wire with ICE Hydrophilic Coating, 300 cm length
• Code Information: Individual Devices in Pouches with Catalog No. 12155-01, UPN H74912155011, Lot Number 4773987, exp. date 2004-5. These pouches were packaged in two lots of five-pack boxes with the following codes: Catalog 12155-01, lot 4791304 Catalog 12155-01, lot 4798294
• Recalling Firm/ Manufacturer: Symbiosis Corp.; 8600 NW 41th Street; Miami FL 33166
• Manufacturer Reason for Recall: Product labeled as Scimed ChoICE PT Extra Suport PTCA Guide Wire 300 cm were actually Scimed PT Graphix Intermediate PTCA Guide Wire 300 cm
• FDA Determined Cause: Other
• Action: Recall letters with response forms were sent to hosptials via FED EX on 8/22/02. Product was to be returned to Boston Scientific in Quincy, MA.
• Quantity in Commerce: 27/5 pack boxes
• Distribution: Recalled product was shipped to 107 domestic hosptials nationwide and to 2 international acccounts.
• 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