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U.S. Department of Health and Human Services

Class 2 Device Recall HSG Procedure Tray 7Fr

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 Class 2 Device Recall HSG Procedure Tray 7Frsee related information
Date Initiated by FirmDecember 22, 2010
Date PostedNovember 18, 2011
Recall Status1 Terminated 3 on November 30, 2011
Recall NumberZ-0215-2012
Recall Event ID 57585
Product Classification Catheter care tray (kit) - Product Code OHR
ProductAngiotech***HSG Procedure Tray 7Fr***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 (7Fr); 1 - Fixed Volume Syringe - 3cc; 1 - CSR Wrap***Catalog Number: 660007000***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. HSG Catheters are intended for use in the injection of contrast material in the examination of the uterus and fallopian tubes.
Code Information Catalog # 660007000 Lot Number(s): 81781ODR; 82041OSH; 82741Q2H; 82871QBF; 83101QRH; 83431RC7; 90151RYF; 90471SME; 90681T3F; 91131TZL; 91461UMC; 92251W8Z; 92521WOC; 92861XCL; 92941XJ6; 93421YAU; 00531ZJM; 010320FR; 011020JE; 016121GL; 02102297; 0260231B.
Recalling Firm/
Manufacturer		 Medical Device Technologies, Inc.
3600 Sw 47th Ave
Gainesville FL 32608-7555
For Additional Information ContactJayme 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
ActionThe 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 Commerce921 boxes
DistributionWorldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
Total Product Life CycleTPLC 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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