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Crédits
Devices
Device Recall Bone Marrow Tray
Modèle / numéro de série
Catalog # BMT1601 Lot Number(s): 91531UQN; 00481ZHG; 012520UD; 024422SW.
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
Description du dispositif
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 - 16ga x 2.688" Bone Marrow Needle "I" Type; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 10 - Micro Slides - Frosted end; 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2"x3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - Amber Specimen Bottle w/ Cap; 1 - Specimen Label; 1 - Stirring Rod; 1 - CSR Wrap***Catalog Number: BMT1601***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.
Manufacturer
Medical Device Technologies, Inc.
1 Event
Rappel de Device Recall Bone Marrow Tray
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Fabricant
Medical Device Technologies, Inc.
Adresse du fabricant
Medical Device Technologies, Inc., 3600 Sw 47th Ave, Gainesville FL 32608-7555
Société-mère du fabricant (2017)
RoundTable Healthcare Partners Lp
Source
USFDA
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Device Recall Bone Marrow Tray
Modèle / numéro de série
Catalog # BMT1000 Lot Number(s): 00611ZPC; 010920I3; 022222F8; 91591UW4; 93081XPS.
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
Description du dispositif
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.
Manufacturer
Medical Device Technologies, Inc.
Device Recall Bone Marrow Tray
Modèle / numéro de série
Catalog # BMT1501 Lot Number(s): 91341UFG; 91891VIO; 92381WH3; 92801X9J; 00611ZPD; 010320FY; 018921XQ.
Classification du dispositif
General and Plastic Surgery Devices
Classe de dispositif
1
Dispositif implanté ?
No
Distribution
Worldwide distribution: US (nationwide) and countries of: Canada, Columbia, Costa Rica, Japan, Mexico, Peru and Saudi Arabia.
Description du dispositif
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 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 10 - Micro Slides - Frosted end; 1 - 1% Lidocaine (5mL); 1 - #11 Mini Scalpel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - 2"x3" ADH Dressing; 1 - Towel; 1 - Fenestrated Drape; 1 - Amber Specimen Bottle w/ Cap; 1 - Specimen Label; 1 - Stirring Rod; 1 - CSR Wrap***Catalog Number: BMT1501***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.
Manufacturer
Medical Device Technologies, Inc.
Language
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