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U.S. Department of Health and Human Services

Class 2 Device Recall Custom General Biopsy Tray

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  Class 2 Device Recall Custom General Biopsy Tray see related information
Date Initiated by Firm December 22, 2010
Date Posted November 18, 2011
Recall Status1 Terminated 3 on November 30, 2011
Recall Number Z-0241-2012
Recall Event ID 57585
Product Classification Single use instrument tray kit - Product Code OJV
Product Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - Needle Safety Foam Block; 2 - 10cc Syringe L/L; 4 - Towel; 1 - Ruler; 1 - 4" x 4" Sponges in stacks of 5; 1 - ¿" x 3" Bandage; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 2% Lidocaine (10mL) ; 1 - CSR Wrap***Catalog Number: CG0287***Sterile - For single patient use. STERILE EO. Caution: Federal (USA) Law restricts this device to sale by or on the order of a physician.

MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW Ave. Gainesville, FL 32808 U.S.A. Domestic: 877-991-1110, International: 732-626-6466, customer_service@angio.com, www.angiotech.com.

Intended for the purpose of harvesting bone and/or bone marrow specimens.

Code Information Catalog # CG0287 Lot Number(s): 91381UGY.
Recalling Firm/
Manufacturer
Medical Device Technologies, Inc.
3600 Sw 47th Ave
Gainesville FL 32608-7555
For Additional Information Contact Jayme Wilson
352-338-0440 Ext. 350
Manufacturer Reason
for Recall
Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays distributed between December 2007 and December 14, 2010 for package integrity.
FDA Determined
Cause 2
Packaging
Action The firm, Angiotech, sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 22, 2010 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to review their current inventory, segregate the affected lot numbers and complete and return the attached Customer Acknowledgement Form via fax to our Quality Assurance department at 1.352.338.0662 or 1.800.333.0440 to arrange for return of the identified product. If you have any questions concerning this notification, call (352) 338.0440 ext. 355 or ext 358.
Quantity in Commerce 20 boxes
Distribution Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
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.
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