Recall Z-0220-2012
Medical Device Technologies, Inc. · initiated December 22, 2010
Product
Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x 1-1/2" Filter Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 Amber Specimen Bottle w/ Cap; 1 - Specimen Label; 1 - #11 Mini Scalpel; 10 - Micro Slides - Frosted end; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - Stirring Rod; 1 - 2"x3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - CSR Wrap ***Catalog Number: BMT1000***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. Intended for the purpose of harvesting bone and/or bone marrow specimens.
Codes / lots: Catalog # BMT1000 Lot Number(s): 00611ZPC; 010920I3; 022222F8; 91591UW4; 93081XPS.
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: Packaging
Action taken
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.
Details
- Recall number
- Z-0220-2012
- Initiated
- December 22, 2010
- Posted by FDA
- November 18, 2011
- Terminated
- November 30, 2011
- Product code
- OJV – Single Use Instrument Tray
- Quantity
- 208
- Distribution
- Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
- Recalling firm
- Medical Device Technologies, Inc., Gainesville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0214-2012 | Angiotech***HSG Procedure Tray 5Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1-…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0215-2012 | Angiotech***HSG Procedure Tray 7Fr***1 - 18ga x 1-1/2" Needle; 1 - Fenestrated Drape; 1-…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0216-2012 | Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0217-2012 | Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0218-2012 | Angiotech***T-Lok Ecomony Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0219-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0221-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0222-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0223-2012 | Angiotech***T-Lok Bone Marrow Tray w/ Safety Needles***1 - #11 Retractable Scalpel; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0224-2012 | Angiotech***T-Lok Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0225-2012 | Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0226-2012 | Angiotech***Bone Marrow Tray***1 - 20cc Syringe L/L; 1 - 5cc Syringe L/L; 1 - 19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0227-2012 | Angiotech***Custom Bone Marrow Tray for New York Hospital/Cornell Medical Center*** 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0228-2012 | Angiotech***Custom Bone Marrow Tray for University of Chicago*** 2- 20ga x 1 " Safety…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0229-2012 | Angiotech***Custom Bone Marrow Tray for University of CA, Davis*** 1 - 10cc Syringe L/L…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0230-2012 | Angiotech***Custom Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0231-2012 | Angiotech***Custom Bone Marrow Tray for Kaiser Foundation Hospitals*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0232-2012 | Angiotech***Custom Bone Marrow Tray for Tyler Hematology Oncology*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0233-2012 | Angiotech***Custom Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 -Fenestrated Drape; 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0234-2012 | Angiotech***Custom Bone Marrow Tray for Hackensack University Medical Center*** 1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0235-2012 | Angiotech***Custom Bone Marrow Tray for High Point Regional Hospital*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0236-2012 | Angiotech***Custom General Biopsy Tray for Emory University Hospital*** 1 - CSR Wrap 48"…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0237-2012 | Angiotech***Custom General Biopsy Tray for University of Rochester Medical Center***1 -…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0238-2012 | Angiotech***Custom General Biopsy Tray for OMA North of Oklahoma City*** 1 - 60cc…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0239-2012 | Angiotech***Custom General Biopsy Tray for Palos Community Hospital*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0240-2012 | Angiotech***Custom General Biopsy Tray for St. Johns Mercy Hospital*** 1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0241-2012 | Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 1 - #11 Mini Scalpel…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0242-2012 | Angiotech***Custom General Biopsy Tray for Lenox Hill Hospital*** 4 -Towel; 1 -19ga x…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0243-2012 | Angiotech***General Biopsy Tray*** 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 1 - 5cc…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |
| Z-0244-2012 | Angiotech*** Custom Bone Marrow Tray for Louis Weiss Memorial Hospital***1 - #11 Mini…Medical Device Technologies, Inc. dba Angiotech, is recalling HSG Procedure Trays and Bone Biopsy Trays… | 12/22/2010Terminated |