5 results
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30ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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RX Daytona Plus (with ISE/without ISE); Models Nos. RX4040 (w/ISE) and RX4041 (without ISE) - Product Usage: A fully automated, random access, clinical chemistry analyzer complete with dedicated analyzer software. For use in clinical laboratories.
FDA Recall
Terminated
·Randox Laboratories, Limited Ardmore; 55 The Diamond Road Crumlin United Kingdom·Product code JJE·December 19, 2019
CATARACT PACK- OJOS INC.- (1) TABLE COVER REINF. 44" X 78" L/F (2) MEDICINE CUP 1oz. (2) ABSORBENT TOWEL 15" X 20" LIF (1 0) EYE SPEAR MICRO SPONGE (1) EYE PAD 2 1/8 X 2 5/8 LIF (4) DRAPE UTILITY LIF (1) EYE SHIELD UNIVERSAL (2) GOWN LGE STANDARD SMS VELCRO/NECK (1) MAYO STAND COVER REINF. LIF (1) EYE DRAPE LIF (1) SYRINGE 3cc W/0 NDL L/LOCK LIF (1) WIPE INSTRUMENT 1MM L/F 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
OPHTALMIC PACK- (1) TABLE COVER REINF. 44" X 78" UF (1) GOWN SMS XLGE STD UF (2) TOWEL ABSORBENT 15" X 20" LIF (1) SYRINGE 3cc W/0 NDL LILOCK UF (1) MAYO STAND COVER REINF. LIF (1) NEEDLE HYPODERMIC 18G X 1% ST. UF (10) EYE MICRO SPONGE UF (2) LABEL CONTRAST BLUE (1) GOWN LGE STD SMS (1) WIPE INSTRUMENT 1MM (1) EYE DRAPE UF (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) IODINE POVIDONE 1oz. (1) EYE SHIELD UNIVERSAL L/F (10) APPLICATOR COTION 6" WOOD (1) BALANCED SALT SOLUTION 18ML LIF (10) GAUZE SPONGE 4" X 4" 12P Y UF (1) LABEL BSS (1) TRAY 3/COMPARTMENT LIF (1) LABEL EPINEPHRINE VIOLET/WHITE (1) LABEL IODINE WHITE/BLACK 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
AIA-2000 Analyzer, Model Nos. AIA-2000LA, AIA-2000ST - Product Usage: The AIA-2000 is capable of performing three methods of immunoassay: an immunoenzymetric (IEMA) or sandwich immunoassay, a competitive binding (EIA) immunoassay, and a two-step immunoenzymetric immunoassay. An antigen-antibody reaction begins by combining a patient sample, control, or calibrator with a diluent in an immunoreaction test cup from the AIA-PACK reagent series.
FDA Recall
Terminated
·Tosoh Bioscience Inc·Product code KHO·September 28, 2018
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