13 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58" SMS (1) BANDAGE GAUZE 4" STRETCH (1) NEEDLE HYPODERMIC 25G X 5/8" (1) STOCKINETTE 6" X 48" LIF (2) CLOTH HUCK TOWEL BLUE (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) GOWN SURGICAL REINF XL TOWEL/WRAP (1) NEEDLE HYPODERMIC 18G X 1 %" (10) GAUZE SPONGE 4" X 4" 16PLY XRD L.F (1) UTILITY BOWL 16oz LIF (1) ABSORBENT TOWELS 15" X 20" LIF (1) CAST PADDING (2) SURGICAL BLADE #15 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET EXTREMITY ABS. 125" x 85" SMS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x 10" (1) CESAREAN DRAPE 71" x 125" LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10) LAP SPONGES PREWASH XRD LIF (1) BABY BEANNIES (1) SCALPEL #10 WITH HANDLE STAINLESS STEEL (1) DRAPE SHEET 42" X 57" SMS (1) EAR ULCER SYRINGE 2oz. UF (1) RECEIVING BLANKET 100% COTTON (1) SCALPEL #20 WITH HANDLE (1) DURAPREP SURGICAL SOLUTION 26ml UF (2) ABSORBENT TOWEL 15" X 20" L.F (2) LITE GLOVES UF (1) BOWL WITH LID PLASTIC 80oz. (1) TABLE COVER REINFORCED 44" x 78" LIF (1) UTILITY BOWL 32oz (2) PAD OBSTETRICAL X-LARGE ST. (1) WRAPPER 30" X 30" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT Y." X 12' UF (1) MUCUSTRAP 20cc 1 OFR (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) UMBILICAL CORD CLAMP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·October 25, 2018
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
FDA Recall
Terminated
·Maquet Cardiovascular Us Sales, Llc·Product code DTZ·October 25, 2018
First Breath Adult Venturi Oxygen Mask with Corrugated Tubing, O2 Diluter Jets (6), Oxygen Tubing, and Nebulizer Hood. (Non-latex) 50/CA Reorder Number: 002610 For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BYF·February 11, 2011
Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DYF·July 12, 2013
Shandon Rapid Chrome Kwik-Diff Kit Part Number: 9990700 Shandon Rapid Chrome Kwik-Diff Reagent #3 Part Number 9990707 Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990700 is sold as a kit in 500ml bottles. Shandon Rapid Chrome Kwik-Diff Kit, Part Number 9990707 is sold as a reagent in a 4L bottle. Intended for use as a kit in special stain techniques.
FDA Recall
Terminated
·Richard-Allan Scientific Company·Product code HYF·March 15, 2017
Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.
FDA Recall
Terminated
·Salter Laboratories, Division of Regulatory Affairs·Product code BYF·March 25, 2011
Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DYF·July 12, 2013
Value Pack General Anesthesia Kit, (containing Reorder Number: 001421 Oxygen Face Mask) Reorder Number: VP1302 For acute use, e.g. Post-op recovery, minimal trauma, patient transfer; used for patients requiring more oxygen than is delivered via a standard nasal cannula (>6L/minute). During inspiration, the patient draws gases both from the oxygen flowing into the mask through the tubing as well as the room via ports on the sides of the mask. Oxygen concentration delivered is 40 60% depending on the patients breathing rate and tidal volume
FDA Recall
Terminated
·Smiths Medical Hythe Hythe, Kent United Kingdom·Product code BYF·February 11, 2011
Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
FDA Recall
Terminated
·Atrium Medical Corporation·Product code DYF·July 12, 2013
CARPALTUNNELLARGE - (1) TABLE COVER 50" X 90" REINFORCED LIF (1) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) UTILITY BOWL 32oz LIF (2) DRAPE SHEET 41 " X 58" SMS (1) BANDAGE GAUZE 4" STRETCH (1) NEEDLE HYPODERMIC 25G X 5/8" (1) STOCKINETTE 6" X 48" LIF (2) CLOTH HUCK TOWEL BLUE (1) GOWN SMS LARGE NON REINFORCED TOWEL/WRAP (1) GOWN SURGICAL REINF XL TOWEL/WRAP (1) NEEDLE HYPODERMIC 18G X 1 %" (10) GAUZE SPONGE 4" X 4" 16PLY XRD L.F (1) UTILITY BOWL 16oz LIF (1) ABSORBENT TOWELS 15" X 20" LIF (1) CAST PADDING (2) SURGICAL BLADE #15 STAINLESS STEEL (4) DRAPE UTILITY WITH TAPE L/F (1) SHEET EXTREMITY ABS. 125" x 85" SMS 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
CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x 10" (1) CESAREAN DRAPE 71" x 125" LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10) LAP SPONGES PREWASH XRD LIF (1) BABY BEANNIES (1) SCALPEL #10 WITH HANDLE STAINLESS STEEL (1) DRAPE SHEET 42" X 57" SMS (1) EAR ULCER SYRINGE 2oz. UF (1) RECEIVING BLANKET 100% COTTON (1) SCALPEL #20 WITH HANDLE (1) DURAPREP SURGICAL SOLUTION 26ml UF (2) ABSORBENT TOWEL 15" X 20" L.F (2) LITE GLOVES UF (1) BOWL WITH LID PLASTIC 80oz. (1) TABLE COVER REINFORCED 44" x 78" LIF (1) UTILITY BOWL 32oz (2) PAD OBSTETRICAL X-LARGE ST. (1) WRAPPER 30" X 30" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT Y." X 12' UF (1) MUCUSTRAP 20cc 1 OFR (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) UMBILICAL CORD CLAMP 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 OHM·May 20, 2014