Recall Z-0237-2012 ยท OJV Single Use Instrument Tray
Medical Device Technologies, Inc.
Angiotech***Custom General Biopsy Tray for University of Rochester Medical Center***1 - Fenestrated Drape; 1 - 19ga x 1-1/2" Filter Needle; 1 - 22ga x 1-1/2" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 10cc Syringe L/L; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 2 - 1% Lidocaine (5mL); 1 - " x 3" Bandage; 1 - Towel; 1 - CSR Wrap; 1 - Lidocaine Insert; 1 - Ruler with Protractor; 1 - 4" x 4" Spo
| Date | Nov 18, 2011 (initiated Dec 22, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 40 boxes |
| Distribution | Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.