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U.S. Department of Health and Human Services

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

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  Class 3 Device Recall ChoICE PT "J" Tip 182 cm guide Wire see related information
Date Initiated by Firm July 16, 2002
Date Posted February 27, 2003
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = SCIMED LIFE SYSTEMS, INC.
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