Device Recall Custom Bone Marrow Tray

Catalog # CB0033TL Lot Number(s): 90911TKI; 90971TPD; 91701V4S; 91731V66; 91871VGY; 92031VTI; 92381WGW; 92591WSR; 92601WU6; 93491YF5; 00121YRN; 0081200P; 013020WM; 0138212I; 017621P8; 02142298; 023222ME.

General and Plastic Surgery Devices

1

No

Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.

Angiotech***Custom Bone Marrow Tray for New York Hospital/Cornell Medical Center*** 1 - 18ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle; 1 - 22ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 20cc Syringe L/L; 1 - 10cc Syringe L/L; 2 - 10cc Syringe L/S; 1 - Obturator; 1 - Male Luer Cap; 20 - Micro Slides - Frosted end; 1 - T-Lok Extraction Cannula; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 4 - Ampule Breaker; 2 - 10% Povidone Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Long Handle Scalpel; 4 - 3" x 3" Sponges in stacks of 5 (4-Ply); 4 -Alcohol Swab Sticks; 4 - 1% Lidocaine (5mL); 1 - 2"x3" ADH Dressing; 3 - Towels; 1 - Probe Guide; 1 - Fenestrated Drape; 1 - CSR Wrap; 1 - 19ga x 1-1/2" Filter Needle ***Catalog Number: CB0033TL***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.

Catalog # CB00541TL Lot Number(s): 73311K5C; 80101KUO; 80151KXQ; 80241L5A; 80351LA3; 80441LG5; 80591LQU; 81151MYT; 81621NYU; 81761OBG; 82121OY8; 82271PA2; 82551PUB; 82751Q49; 82971QIV; 83371R7R; 83451RG8; 83531RMM; 90081RTG; 90271S56; 90421SJG; 90471SLI; 90781TBN; 90911TKA; 91411UKY; 91591UWH; 91801VBK; 92031VTD; 92301WC9; 92801X9N; 93341Y4W; 93431YCA; 00681ZSI; 00912095; 013020WP; 016521HZ; 018721UA; 0210229A.

General and Plastic Surgery Devices

1

No

Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.

Angiotech***Custom Bone Marrow Tray for University of Chicago*** 2- 20ga x 1 ¿" Safety Needle; 1 21ga x 1-1/2" Safety Needle; 1 25ga x 5/8" Safety Needle; 1 - 10cc Syringe L/L; 2 - 20cc Syringe L/L; 3 - 4" x 4" Sponges in stacks of 5; 2 - 3" x 3" Sponges in stacks of 5; 1 - CSR Wrap; 2 - Fenestrated Drape; 1 - 5" Hemostat Straight Mosquito; 1 - #11 Retractable Scalpel; 1 - 8ga x 4" Bone Marrow Needle "J" Type; 1 - 16ga x 2.688" Bone Marrow Needle "I" Type; 1 - Probe Guide; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Obturator; 2 - Petri Dish***Catalog Number: CB00541TL***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.

Catalog # CB0140TL Lot Number(s): 82271PA3; 82871QAS; 91041TRM; 92011VRH; 92571WRD; 00411ZC0; 00471ZGA; 00481ZHB; 025622YA; 032112459.

General and Plastic Surgery Devices

1

No

Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.

Angiotech***Custom Bone Marrow Tray for University of CA, Davis*** 1 - 10cc Syringe L/L; 1 - 20cc 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 - 8ga x 4" Bone Marrow Needed "J" Type; 1 15ga x 4" Bone Marrow Needle "I" Type; 1 - T- Lok Extraction Cannula; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - Probe Guide; 1 - Obturator; 2 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 2 - 4" x 4" Sponges in stacks of 5; 1 - 2" x 3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - Male Luer Cap; 1 - CSR Wrap***Catalog Number: CB0140TL***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.

Catalog # CB0181TL Lot Number(s): 83371R82; 91201U5W; 018721VC; 028023D1.

General and Plastic Surgery Devices

1

No

Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.

Angiotech***Custom Bone Marrow Tray*** 1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1 - 23ga x 1" Needle; 1 - 18ga x 3-1/2" Needle; 1 - 25ga x 5/8" Needle; 3 - 10cc Syringe L/S; 2 - 1% Lidocaine (5mL); 1 - Male Luer Cap; 1 - Fenestrated Drape; 1 - CSR Wrap; 1 10% Providone Iodine Swab Sticks (3/Pkg.); 3 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 2" x 3" ADH Dressing; 1 - Towel; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - 11ga x 4" Bone Marrow Needed "J" Type; 1 - Probe Guide; 1 - Obturator; 1 - T-Lok Extraction Cannula***Catalog Number: CB0181TL***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.

Catalog # CB0187TL Lot Number(s): 82481PO6; 82821Q8T; 83251R3E; 90081RTF; 91881VHV; 91881VHX.

General and Plastic Surgery Devices

1

No

Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.

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; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Probe Guide; 1 - Obturator; 1 - T-Lok Extraction Cannula; ***Catalog Number: CB0187TL***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.