Recall Z-0231-2012 · OJV Single Use Instrument Tray

Medical Device Technologies, Inc.

Angiotech***Custom Bone Marrow Tray for Kaiser Foundation Hospitals*** 1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 1-1/2" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2" x 3" ADH Dressing; 1 - Towel; 1 - Stirring Rod;

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	93 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.