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Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.

FDA Recall
Terminated ·China Daheng Group Inc. # A9 Shangdi Xinxilu Haidian District Beijing China·Product code LYB·July 15, 2013

IMPLANTE DE ORTHOPEDIA- 1) GOWN IMPERV. XTRA REINF. XL SMS T/WRAP LEVEL IV (1) CAUTERY TIP POLISHER LIF (1) DURAPREP SURGICAL SOLUTION 26ml LIF (1) BAG SUTURE FLORAL LIF (1) TUBE SUCTION CONNECT. Y.!" X 12' L/F (1) CAUTERY PENCIL ROCKER SWITCH LIF (2) *Pr. SURGEON NEUTRALON GLOVE# 8 LATEX (2) BLADE SURGICAL# 10 STAINLESS STEEL (1) BAG GLASSINE (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (2) LITE GLOVE LIF (1) SPLIT SHEET W/ADHES 108" X 77" STD SMS UF (1) MAYO STAND COVER REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (5) ABSORBENT TOWELS 15" X 20" LIF (5) LAP SPONGES PRE-WASH XRD LIF (2) DRAPE SHEET 70" X 100" STD SMS LIF (1) MAYO TRAY LARGE (2) * Pr. SURGEON NEUTRALON GLOVE #8% LATEX (1) STAPLE SKIN WIDE 35 ST. LIF (1) TOP DRAPE W/ADHES. 108" X 50" STD SMS LIF (1) BULB SYRINGE 60cc (2) BANDAGE ELASTIC 6" X 5"yds LIF (2) UTILITY BOWL 32oz (1) UTILITY BOWL 16oz LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" LIF (2) ABDOMINAL PAD 8" X 7 W (1) U-DRAPE 60" X 70" WIT APE SPLIT 6" X 21' (2) GOWN IMPERVIOUS REINFORCED XL (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" X 21" (1) BAG SUTURE FLORAL (2) ABDOMINAL PAD 8" X 7 Y:z" (1) TUBE SUCTION CONNECT. }4" X 12' (1) DURAPREP SURGICAL SOLUTION 26ml (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE WITHOUT VENT (2) LITE GLOVE (1) SPLIT SHEET WITH ADHES 1 08" X 77" STD SMS (2) COVER TABLE BTC 77" X 86" HD FULL COVERAGE (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) MAYO STAND COVER REINFORCED (1) INCISE DRAPE ANTIMICROBIAL 23" X 17" (5) ABSORBENT TOWELS 15" X 20" (1) GOWN IMPERV. EXTRA REINFORCED XL SMS TNI/RAP LEVEL IV (4) DRAPE UTILITY (1) CAUTERY PENCIL ROCKER SWITCH (5) LAP SPONGES PREWASH XRD (1) GOWN IMPERVIOUS REINFORCED SMS X-LARGE (2) DRAPE SHEET 70" X 100" STD SMS (1) TIME OUT BEACON NON WOVEN (1) STAPLE SKIN WIDE 35 ST. (1) SKIN MARKER INK WITH 8 LABEL/TIME OUT/RULER (1) MAYO TRAY LARGE (1) NEEDLE & BLADE COUNTER 20c FOAM/MAG (1) TOP DRAPE W/ADHES. 100" X 53" SMS (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL WRAP (2) BANDAGE ELASTIC 6" X 5"yds (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK (1) UTILITY BOWL 16oz (1) NEEDLE HYPODERMIC 18G X 1Y2 (2) UTILITY BOWL 32oz (2) BLADE SURGICAL# 10 STAINLESS STEEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

ORTHOPEDIC IMPLANT PACK CUSTOMED USA, CODE 900-2903 CONTENTS: (1) CAUTERY TIP POLISHER UF (1) SKIN MARKER W/RULER (1) BAG SUTURE FLORAL (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21" (1) TUBE SUCTION CONNECT W' X 12' UF (2) PAD ABDOMINAL 8" X 7.5" (1) BAG GLASSINE (1) YANKAUER SUCTION TUBE W/0 VENT LIF (2) LITE GLOVE UF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (2) TABLE COVER REINFORCED 50" X 90" LIF (1) BLADE SURGICAL# 10 STAINLESS STEEL (1) MAYO STAND COVER REINFORCED LIF (1) SHEET SPLIT W/ADHES 108" X 77" STD SMS L/F (5) TOWELS ABSORBENT 15" X 20" UF (1) STOKINETIE IMPERVIOUS 14" X 48" LIF (2) DRAPE SHEET 70" X 100" LIF (1) *GLOVE# 7'!h SURGEON NEUTRALON LATEX (5) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) *GLOVE # 8 SURGEON NEUTRALON LATEX (1) SKIN STAPLE 35 WIDE UF (1) *GLOVE# 8'!h SURGEON NEUTRALON LATEX (1) TRAY MAYO LGE (1) GOWN SURG REINFORCED XL TOWEUWRAP (1) DRAPE TOP W/ADHES 108" X 50" STD SMS UF (2) GOWN XL SMS IMPERVIOUS REINFORCED UF (1) BULB SYRINGE 60cc CLEAR (1) CAUTERY PENCYL ROCKER SWITCH UF (1) UTILITY BOWL 16oz LIF (1) BLADE SURGICAL# 20 STAINLESS STEEL (1) UTILITY BOWL QUART 32oz LIF (4) DRAPE UTILITY WITAPE UF (1) DRAPE INCISION 23" X 17" UF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

MINOR PACK CONTENTS: (1) TOWELS ABSORBENT 15" X 20" (1) WRAPPER 24" X 24" (16) GAUZE SPONGES 2" X 2" 8PLY (1) TRAY HALF SHALLOW (12) COTION TIP APPLICATOR 6" WOOD (2) GLOVE SKY NITRILE PF BLUE MED (18) GAUZE SPONGES 4" X 4" 12PLY (1) SMALL DRAPE W/ADH APERTURE POUCH Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJK·May 20, 2014

PERl GYN PACK (1) TABLE COVER 44" x 90" (2) LEGGINS W/7" CUFF 30" x 42" (1) ABDOMINAL DRAPE WITH TAPE LIF (2) TOWELS ABSORBENT 15" X 20" (10) GAUZE SPONGE 4" X 4" 16PLY (2) DRESSING NON ADH TELFA 4" X 3" (1) ROBINSON RED CATHETER 14FR. (1) UNDERBUTTOCK DRAPE WITH POUCH EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OKV·May 20, 2014

ORTHOPEDIC PACK I (2) CUSTOMED, 900-2503, contains: (2) TOWELS ABSORBENT 15" X 20" LIF (1) COVER MAYO STAND REINFORCED L/F ( 1) U- DRAPE 60" X 70" W/TAPE SPLIT 6 X 21LIF (1) DRAPE % ECONOMY 53" X 77" LIF (4) DRAPE UTILITY WIT APE LIF (1) BAG SUTURE FLORAL LIF (1) SHEET SPLIT W/ADHES 1 08" X 77" LIF (1) COVER TABLE REINFORCED 50" X 90" LIF Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

Angiotech***T-Lok Ecomony 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 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - CSR Wrap; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 1 - Towel; 1 - Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing***Catalog Number: BMET1104ATL***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.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

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, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

Angiotech***Custom Bone Marrow Tray for High Point Regional Hospital*** 1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 1 - 10cc Syringe L/L; 3 - 20cc Syringe L/L; 1 - Probe Guide; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 3 - 4" x 4" Sponges in stacks of 5; 1 - Towel; 1 - 2" x 3" ADH Dressing; 1 - Specimen Label; 1 - Obturator; 1 - Male Luer Cap; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - T-Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0387TL***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.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

Angiotech***Custom Bone Marrow Tray for Tyler Hematology Oncology*** 1 - #11 Mini Scalpel; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 25ga x 1-1/2" Needle; 1 - 10cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Providone Iodine Swab Sticks (3/Pkg.); 1 - 4" x 4" Sponges in stacks of 5; 1 - 2" x 3" ADH Dressing; 2 - Towel; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Probe Guide; 1 - Obturator; 1 - T-Lok Extraction Cannula; ***Catalog Number: CB0202TL***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.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

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, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

Angiotech***Custom Bone Marrow Tray for Hackensack University Medical Center*** 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 25ga x 5/8" Needle;1 - 5cc Syringe L/L; 2 -10cc Syringe L/L; 1 - Male Luer Cap; 1 - Glass Slide Poly Bag; 1 - 10% Povidone Iodine Swab Sticks (3/Pkg); 1 - 1% Lidocaine (5mL); 1 - 2" x 3" ADH Dressing; 1 - Towel; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 10 - Micro Slides Frosted end; 1 - 15ga x 2.688" Bone Marrow Needle "I" Type; 1 - CSR Wrap***Catalog Number: CB0370***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.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

Angiotech***T-Lok Ecomony 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 - 11ga x 4" Bone Marrow Needle "J" Type; 1 16ga x 2.688" Bone Marrow Needle "I" Typ; 1 - 3" x 3" Sponges (4-Ply); 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; 1 - Towel; 1 - 2"x3" ADH Dressing; 1 - CSR Wrap; ***Catalog Number: BMET1104TL***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.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

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, [email protected], www.angiotech.com. Intended for the purpose of harvesting bone and/or bone marrow specimens.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

ORTHOPEDIC PACK BASIC CODE 900-2830. CONTENTS: (3) TOWELS ABSORBENT 15" X 20" (1) COVER MAYO STAND REINFORCED (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6 X 21 SPLIT (1) DRAPE% ECONOMY 53" X 77" (4) DRAPE UTILITY WITH TAPE (1) BAG SUTURE FLORAL (1) SHEET SPLITW/ADHES 108" X 77" STD SMS (1) COVER TABLE REINFORCED 50" X 90" (1) STOCKINETTE IMPERVIOUS 14" X 48" (1) TIME OUT BEACON NON WOVEN (1) GOWN XL SMS IMPERVIOUS REINFORCED AAMI LEVEL Ill (1) POLISHER CAUTERY TIP (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER (1) COUNTER NDLIBLADE 20C FOAM/MAG (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER (1) GOWN IMPERVIOUS EXTRA REINFORCED LGE T/WRAP AAMI LEVEL Il (1) BAG GLASSINE PLAIN (1) ELECTRODE DUAL DEPRES Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall
Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code OJH·May 20, 2014

Angiotech*** Custom Bone Marrow Tray for Louis Weiss Memorial Hospital***1 - #11 Mini Scalpel; 1 - 20ga x 1-1/2" Needle; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 1cc Syringe L/L; 1 - 5cc Syringe L/L; 2 - 10cc Syringe L/L; 1 Needle Safety Foam Block, Large; 1 - Fenestrated Drape; 1 - Male Luer Cap; 1 - CSR Wrap; 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4" x 4" Sponges in stacks of 5; 1 - 2"x 3" ADH Dressing; 1 - Towel; 4 Alcohol Swab Sticks; 20 - Micro Slides - Frosted end; 1 - T-Lok Extraction Cannula; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4 Bone Marrow Needle J Type; 1 - Probe Guide; 1 Obturator.***Catalog Number: CB0318TL***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.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

Angiotech*** Custom Bone Marrow Tray***1 - #11 Mini Scalpel; 1 - Fenestrated Drape; 1 - 21ga x 1-1/2" Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 25ga x 5/8" Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - Probe Guide; 1 Obturator; 1 - Male Luer Cap; 1 - 10% Povidone-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 15ga x 4" Bone Marrow Needle "I" Type; 1 - 2% Lidocaine (10mL); 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - T-Lok Extraction Cannula; 1 - CSR Wrap***Catalog Number: CB0355TL***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.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

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 -11ga x 4" Bone Marrow Needle "J" Type; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 - Specimen Label; 1 - Stirring Rod; 1 - 3" x 3" Sponges in stacks of 5 (4-Ply); 1 - CSR Wrap; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 -Probe Guide; 1 - Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - Towel; 1 - 2"x3" ADH Dressing; 10 - Micro Slides - Frosted end; 1 - Glass Slide Poly Bag***Catalog Number: BMT1104ATL***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.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010

Angiotech***T-Lok Bone Marrow Tray w/ Safety Needles***1 - #11 Retractable Scalpel; 1 - 21ga x 1-1/2" Safety Needle; 1 - 25ga x 5/8" Safety Needle; 1 - 19ga x 1-1/2" Filter Needle; 1 - 5cc Syringe L/L; 1 - 20cc Syringe L/L; 1 - 11ga x 4" Bone Marrow Needle "J" Type; 1 - Specimen Label; 5 - 3" x 3" Sponges (4-Ply); 1 - CSR Wrap; 1 - 6/7 Dram Snap Cap Vials-Amber; 1 - Stirring Rod; 1 - Fenestrated Drape; 1 - 1% Lidocaine (5mL); 1 - 10% Povidone-Iodine Swab Sticks (3/Pkg); 2 - 4mL Specimen Tube w/EDTA; 1 - Probe Guide; 1 -Obturator; 1 - Male Luer Cap; 1 - T-Lok Extraction Cannula; 1 - 2"x3" ADH Dressing; 10 - Micro Slides - Frosted end; 1 - Towel; 3 - NeedleVISE***Catalog Number: BMT1104STL***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.

FDA Recall
Terminated ·Medical Device Technologies, Inc.·Product code OJV·December 22, 2010