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U.S. Department of Health and Human Services

Class 3 Device Recall SourceOne Healthcare TechnoUltrasound trays.

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  Class 3 Device Recall SourceOne Healthcare TechnoUltrasound trays. see related information
Date Initiated by Firm January 18, 2005
Date Posted September 21, 2005
Recall Status1 Terminated 3 on February 21, 2007
Recall Number Z-1572-05
Recall Event ID 33314
510(K)Number K854095  
Product Classification General Surgery Tray - Product Code LRO
Product SourceOne Healthcare Technologies brand, Ultrasound Tray, Cat. 255825R1, Lot 0503, Exp. 11-07, packaged as 10 trays per case.
Code Information Lot number 0503, expiration date 11-07.
Recalling Firm/
Manufacturer		 North Coast Medi-Tek Inc
8603 East Ave
Mentor OH 44060-4366
For Additional Information Contact Theresa A. Sokolowski
440-974-0750
Manufacturer Reason
for Recall		 Outside box labeling, containing 10 trays, incorrectly identified the product as ultrasound trays. Product is Breast Biopsy trays, Cat. 255826R2. Individual tray package labeling correctly identifies the product as Breast Biopsy tray.
FDA Determined
Cause 2		 Other
Action The recalling firm sent corrected labels to the distributor for the labeling of all 5 cases that were on hand.
Quantity in Commerce 5 cases, each case containing 10 kits (50 total kits).
Distribution The product was distributed to one customer: Source One Healthcare Technologies distribution center, 4434 Mulhauser Road #300, Hamilton, OH 45011.
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 = LRO and Original Applicant = NORTH COAST MEDI-TEK
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