Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0222-2012

Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle...

Medical Device Technologies, Inc. / initiated 2010-12-22 / Terminated / root cause: packaging

Medical Device Technologies, Inc. began a recall of Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe... on . The reason FDA records is "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". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number
Z-0222-2012
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Medical Device Technologies, Inc.
Product
Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Specimen Label; 1 - Stirring Rod; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 10 - Micro Slides - Frosted end; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 2 - 4mL Specimen Tube w/EDTA; 1 - Towel; 1 - 2"x3" ADH Dressing; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 -Glass Slide Poly Bag; 1 - CSR Wrap; ***Catalog Number: BMT1104BTL***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. Intended for the purpose of harvesting bone and/or bone marrow specimens.
Product code
OJV Single Use Instrument Tray
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.
Root cause tag
packaging
FDA 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 in commerce
2086 boxes
Distribution
Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
Product codes and lots
Catalog # BMT1104BTL Lot Number(s): 90901TID; 91061TUR; 91311UAN; 91541URR; 91541URS; 91611UYC; 91611UYD; 91701V4P; 91821V65; 92191W5U; 92241W8L; 92381WGP; 92661WYK; 92681X1T; 92681X1U; 92721X4H; 92851XBC; 93201XVY; 93211XYD; 93291Y3S; 00131YKH; 00461ZER; 00461ZFF; 00611ZPO; 00671ZRJ; 00751ZYG; 0077200G; 0078200O; 011820P6; 013020WD; 0138212B; 0139213P; 016821KT; 017621P9; 017621PA; 0208227F; 022822I3; 024622UC; 02602315; 0264232Z; 028023D4; 030923WL; 03222469.