86 results
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18ms
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Sources: EU EUDAMED, US FDA
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JAMSHIDI (TJ) NEEDLE BM ASP MAC [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 3.5, d.) 8G x 6, e.) 11G x 6]; STERILE;
FDA Recall
Terminated
·Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017
JAMSHIDI (TJ) NEEDLE BONE MARROW [a.) 13G x 3.5, b.) 8G x 4, c.) 11G x 4, d.) 8G x 6, e.) 11G x 6]; STERILE;
FDA Recall
Terminated
·Carefusion 2200 Inc
75 N Fairway Dr
Vernon Hills IL 60061-1845·Product code FSH·February 23, 2017
TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 15 cm; TJC3513 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 13G x 8.9 cm; TJM4011 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 11G x 10cm; TJC4011 Jamshidi" Bone Marrow Biopsy/Aspiration Needle. 11G x 10cm; TJM4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm; TJC4008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with Marrow Acquisition Cradle. 8G x 10cm;
FDA Recall
Open, Classified
·Bard Peripheral Vascular Inc·Product code KNW·June 23, 2021
Monoject Bone Marrow Biopsy / Aspiration Tray with Safety Components 8G x 4 inch Product Number: 8881847084
FDA Recall
Terminated
·Kendall Healthcare Products Co·Product code FMI·October 8, 2004
TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.
FDA Recall
Terminated
·TiSport, Llc·Product code IOR·September 11, 2018
T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code KNW·June 18, 2015
T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN; T-LOK BONE MARROW BIOPSY NEEDLE 11G x 4 EXT CAN Intended for the purpose of harvesting bone and/or bone marrow specimens
FDA Recall
Terminated
·Argon Medical Devices, Inc·Product code KNW·January 18, 2017
Ebola IgX VP-40 Serum/Plasma/Blood Cassette, Catalog No. I-100 Materials Provided: 1. Test Device 2. Lancet 3. Alcohol pad. 4. Develop buffer tube contain buffer vial (0.3ml)
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
Ebola GP IgX Blood, Serum, Plasma, Cassette, Catalog No. I-101 Materials Provided: 1. Test Device 2. Lancet (optional) 3. Alcohol pad. (optional) 4. Extraction tube (optional) 5. Buffer vial (0.5ml) --- packaged separately, and sufficient for use with up to 40 tests.
FDA Recall
Terminated
·Lusys Laboratories, Inc.·Product code N/A·March 13, 2015
REEMPLAZO DE RODILLA Y CADERA CONTENTS: (6) TOWELS ABSORBENT 15" X 20" (I) PK. STRIP STERICLOSURE Y," X 4" (I) COVER MAYO STAND RErNFORCED (I) SKIN MARKERINK W/8 LABEIJfiME OUT/RULER (I) BAG SUTURE FLORAL (2) SCALPEL WEIGHTED SAFETY # I0 (I) STOCKrNETTE IMPERV 14" X 48" (I) TIME OUT BEACON NON WOVEN (2) DRAPE U 60" X 70"WI TAPE SPLIT 6" X 21 " (2) TUBE SUCTION CONNECT'/.'' X 12' (2) DRAPE INCISE ANTIMICROBIAL 23" X 17" (2) LIGHT SHIELD (I) NEEDLE SPINAL ANESTH 18G X 3 Y, (4) STR IPS TAPE 24" X 4" (I ) GOWN IMP. XTRA REINF SMS XL T/W LEVEL (20)GAUZE SPONGES 4" X 4" 16PLY (3) DRAPE '!. ECONOMY 53" X 77" (I) DRAPE UNDERBUTTOCK W/POUCI-1 44" X 35" (I) DRAPE TOP WIADHESIVE 108" X 50" STD SMS (I) COUNTER NEEDLE 60C FOAM STRIP/MAG STRIP (I) YANKAUER OPEN TIP CLEAR W/0 CIV (2) DRAPE SIDE 36" X 77" W/ADl-1. (I) SHEET SPLIT W/ADHES 108" X 77" STD SMS (I) SYRINGE 60ML UL W/0 NEEDLE (I) POLISHER CAUTERY TIP (I) NEEDLE BLUNT FILL 1 8G X I Y, (2) COVER TABLE BTC 77" X I I 0"l-ID FULL COVERAGE (2) GLOVE SURG. DERMA PRENE #8 POWDER FREE (10) SPONGE LAP PREWASH 18" X 18" XRD (I) COVER MAYO STAND W/CSR 23" X 54" (I) BOWL UTILITY QUART 32oz. (3) CLAMP TOWEL (I) BOWL UTILITY PINT 16oz. (3) GOWN MICROCOOL IMP. XTRA LONG XL (3) BANDAGE ELASTIC 6" X 5YRD WIVELCRO (I) MERLING SKrN PREP APPLIC.39ML (2) PADDING CAST SOFT ROLL 6 X 4YRD (I) MAYO TRAY LARGE 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 LRO·May 20, 2014
NEURO PACK CONTENTS: (4) TOWEL ABSOSRBENT 15" X 20" LIF ( I ) BAG BI OH AZARD 30" X 37" (2) MAYO STAND COYER REINFORCED UF (20) GAUZE SPONGE 4" X 4" 1 6PLY XRD UF ( I ) CAUTERY POLISHER TIP LIF ( I ) BLADE SU RGICAL# II CARBON STEEL (I) TRAY MAYO LARGE (8) TOWELS CLOTH I-l UCK (BLUE) (2) WASH BASIN ROUND 6QT ( I ) NEEDLE HYPODERMIC 1 8G X I \12 ST. (2) UTI LITY BOWL QUART 32oz. (2) BULB SYRINGE 60cc LIF (2) NEEDLE & BLADE COUNTER, IOC M/CLEAR LIF (2) PVP SCRUB 8'' STICK SPONGE ST. (I)SKIN STAPLE 35 WIDE ST. LIF (2) SYRINGE 60ML W/0 NEEDLE LILOCK LIF (2) LITE GLOVE (I) TABLE COYER BTC 79" X 110" HD FULL COVERAGE LIF (2) TUBE SUCTION CONNECT. W' X 1 2' LIF (4) DRAPE UTILI TY WIT APE LIF (5) LAP SPONGE PREWASH 1 8" X 1 8" XRD LIF (I) CAUTERY PENCIL ROCKER SWITCH UF (2) BLADE SURG I CA L # I O CARBON STEEL (I) BLADE SURG I CAL#1 5 CARBON STEEL (I) SKIN MARKER INK W/8 LABEL (3) UTI LITY BOWL 1 6oz. L/F (2) PVP PAINT 8" STICK SPONGE ST. (7) DRAPE :V. ECONOMY 53" X 77" LIF (I)S UTURE BAG FLORAL (I) SY RINGE I Occ SLI P TI P ST. LIF (I) NEEDLE HYPODERM IC 22G X I \12 ST. (I) SOLUTION SURG I CAL DURAPREP 26M L LIF (I) GOWN SURG. REINFORCED LGE TOWEL/ WRAP (2) GOWN FAB REINFORCED X-LARGE SONTARA (I) DRAPE TLAPAROT. 1 02" X 78" X 1 21 " STD SMS 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 OJG·May 20, 2014
EAR PACK CONTENTS: ( I ) B LADE SU RG ICA L # 15 CARBON STEEL ( I ) EMESI S BASIN lO in 700cc ( I ) GOWN XL SMS IM P. REINFORCED ( I ) NEEDLE HYPODERM IC 1 8G X I 'h ( I ) WASH BASIN ROUND 6QT ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT (I) STERI STR I P CLOSURE 'h" X 4" ( I) SYRINGE 3cc WITHOUT NEEDLE LILOCK (2) SYRINGE I ML WITHOUT NEEDLE LILOCK (I) CAUTERY TIP POLISHER (I) SHEET ENT SPLIT 110" X 77" SMS ( I ) GOWN I MP XTRA REINF. SMS XLT/ W LEVEL I V (2) LITE GLOVE (1 2) TOWELS CLOTH HUCK (BLUE) ( I ) TUBE SUCTION CONNECT W' X 1 2' (I) EAR ULCER SYRINGE 2oz (I) TABLE COYER REINFORCED 50" X 90" ( I) UTILITY BOWL 16oz (4) APPLICATOR COTTON 6" WOOD (2) STRJPS TAPE 24" X 4" ( I ) GOWN LGE SMS I MPERVIOUS REINFORCED ( I ) WIPE INSTRUMENT LMM 8.25 X 8.25 ( I ) MAYO STAND COYER REINFORCED ( I ) NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I ) SYRINGE I Occ WITHOUT NEEDLE LILOCK ( I ) MAYOTRAY SMALL ( I ) SYRINGE I Occ TI P CONTROL LUER LOCK ( I ) DRAPE M ICROCOSPE LE I CA 42 X 105 ( I ) TI ME OUT BEACON NON WOVEN (I) BLADE M IN IATURE CARBON STEEL (10) GAUZE SPONGE 4" X 4" 1 6PLY XRD (I) SK I N MARKER INK W/8 LABEL (2) NEEDLE HYPODERM I C 27G X I W' ONE PACK WET SK IN W ITH CONTENTS: ( I ) WRAPPER SMS 30" X 30" (2) COTTON TIP APPLICATOR 6" WOOD (2) GLOVE MED FREETOUCH VYNIL P/F (6) SPONGE W ING SMALL (4) TOWELS ABSORBENT 1 5" X 20" (3) TIP ABSORB. APPLICATOR STI CK SPONGE ( I ) PVP IODOPHOR PAINT 4oz. BOTTLE (I) PVP SCRUB SOLUTION 4oz. BOTTLE (I) TRAY 3/COMPARTMENT 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 OGR·May 20, 2014
Playtex Nurser Deluxe Double Electric Breast Pump, Model X06578AO, powered by a 12V DC power supply, Model SY-12120, which is included with the package.
FDA Recall
Terminated
·Energizer Personal Care·Product code HGX·March 18, 2014
Roche Diagnostics NAPA2, N-Acetyl-Procainamide, COBAS INTEGRA, Roche Diagnostics, Indianapolis, IN.; 20737852322. An in-vitro diagnostic reagent system intended for use on COBAS Integra systems for the qualitative determination of NAPA in serum or plasma.
FDA Recall
Terminated
·Roche Diagnostics Corp.·Product code CGX·June 11, 2008
Sterile double breast personal accessory convenience kit for the Symphony or Lactina Breast pumps; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; article #67116S
FDA Recall
Terminated
·Medela Inc·Product code HGX·August 6, 2010
INJECTOR FORCEMAX UP 2.8MMCH 23G 5MM, model no. NM-400L-0523 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
FDA Recall
Terminated
·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FGX·January 4, 2021
INJECTOR FORCEMAX UP 2.8MMCH 21G 4MM, model no. NM-400L-0421 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
FDA Recall
Terminated
·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FGX·January 4, 2021
INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM, model no. NM-400L-0425 - Product Usage: Used with endoscopes to perform endoscopic injection for the treatment of esophageal and gastric varices and for submucosal injection in the digestive tract.
FDA Recall
Terminated
·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code FGX·January 4, 2021
Sterile single/double breast personal accessory convenience kit for the Lactina Breast pump; the kit connects to a hospital grade breast pump for the removal, collection, and storage of mother's breast milk; Manufactured exclusively by and for Medela, Inc., P.O. Box 660, 1101 Corporate Drive, McHenry, IL 60051-0660; Article #67094S
FDA Recall
Terminated
·Medela Inc·Product code HGX·August 6, 2010
SYNCHRON Systems Modular Creatinine (CREm) Reagent Kit, Part Number: 472525 Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine. CREm reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 800 System and SYNCHRON Systems AQUA CAL 1 and 2, is intended for the quantitative determination of creatinine concentration in human serum, plasma or urine.
FDA Recall
Terminated
·Beckman Coulter Inc.·Product code CGX·August 2, 2010