Angiotech***HSG Procedure Tray 5Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1- 20cc Syringe L/L; 1 - Povidone-Iodine Ointment (1g); 2 - Povidone-Iodine Solution (1oz); 1 - Sanitary Napkin; 2 - Sponge Sticks (6"); 1 - Sound Dilator; 1 - Autobag; 1 - Lubricating Jelly; 2 - Cotton Tipped Swab (8"); 1 Extension Tubing (30"); 2 - 3"x3" Sponges (12-Ply); 1 - Vaginal Speculum; 1 - HSG Catheter (5Fr); 1 - Fixed Volume Syringe - 2cc; 1 - CSR Wrap (30"x30")***Catalog Number: 660005000***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, [email protected], www.angiotech.com. HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.
FDA Recall Z-0214-2012 · Posted 2011-11-18
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Recalling FirmMedical Device Technologies, Inc.
Recall StatusTerminated
Product CodeOHR
Date Initiated2010-12-22
Date Terminated2011-11-30
Product Quantity2902 boxes
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.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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