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U.S. Department of Health and Human Services

Class 3 Device Recall ChoICE PT Extra Support PTCA Guide Wire

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  Class 3 Device Recall ChoICE PT Extra Support PTCA Guide Wire see related information
Date Initiated by Firm August 22, 2002
Date Posted February 27, 2003
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SCIMED LIFE SYSTEMS, INC.
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