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    Oscor PACE 203H, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.

    FDA Recall
    Terminated ·Osypka Medical Inc·Product code DTE·June 30, 2010

    St. Jude Medical, Model 3085, Dual-Chamber External Pulse Generator The PACE 203H / Model 3085 external pulse generator / temporary cardiac pacemaker is designed to be used with cardiac pacing lead systems for temporary atrial or ventricular or A-V sequential pacing. The PACE 203H / Model 3085 has applications where such pacing modes are indicated for therapeutic, prophylactic, or diagnostic purposes.

    FDA Recall
    Terminated ·Osypka Medical Inc·Product code DTE·June 30, 2010

    MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DYNJ89414; 5) CVG BASIN PACK SC, Medline Kit Number/SKU DYNJ38052G; 6) T/A BASIN SET, Medline Kit Number/SKU DYNJ47941F; 7) VALVE BASIN PACK SC, Medline Kit Number/SKU DYNJ38054G.

    FDA Recall
    Open, Classified ·Product code KDD·May 4, 2026

    Convertors Tiburon Cardiovascular Split Drape II, Sterile, for single use only; Cardinal Health, McGaw Park, IL 60085-6787, Made in Mexico The cardiovascular drapes were packagaged under the following configurations: a) Catalog #9158 - 1 CV split drape b) Catalog #9158CE - 8 x 1 CV split drape

    FDA Recall
    Terminated ·Cardinal Health·Product code KKX·September 27, 2006

    Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code PPB·February 11, 2025

    SOFT CONTACT LENSES (toric) packaged under the following labels: (1) CV \ ENCORE toric (methafilcon A) and (2) ONEVUE 55 toric (methafilcon A) flexible wear. Responsible firm on label: Coopervision, Hamble, SO31, 4RF, UK, Scottsville, NY 14546, USA *** Made in UK. The lenses are sold in boxes of 6 and sold individually as trial lenses.

    FDA Recall
    Terminated ·Coopervision Inc·Product code LPL·June 25, 2003

    MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2) CV MINOR CATH LAB PACK, REFDYNJ44997J; 3) PLASTIC PACK, REFDYNJ58409C; 4) GENDER AFFIRMING SURGERY, REFDYNJ66252A; 5) ST CHARLES PORT, REFDYNJ909591

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code OES·October 9, 2024

    MEDLINE Medical Procedure Kits labeled as: 1) BNT CV PACK, Medline Kit Number/SKU DYNJ912271; 2) CV PACK PART 1, Medline Kit Number/SKU DYNJ31204D; 3) KIT PERIPHERAL VASCULAR MMC, Medline Kit Number/SKU DYNJ905368D; 4) KIT PERIVASCULAR MMC, Medline Kit Number/SKU DYNJ905368B; 5) VP SHUNT PACK, Medline Kit Number/SKU DYNJ46530I.

    FDA Recall
    Open, Classified ·Product code OFF·May 4, 2026

    BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D; REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV; REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M; REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV; REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV; REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M; REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV; REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV; REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M; REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV; REF: 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CV; REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M; REF: 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2M; REF: 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M REF: 11419365, BD Alaris" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite" Y-sites REF: 10813621, BD Alaris" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 2423-0007, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 10015896, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite" Y-sites REF: 24010-0007T, BD Alaris" Pump Infusion Set, Bonded Texium", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite" Y-sites REF: 10010483, BD Alaris" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing REF: 2403-0007, BD Alaris" Pump Infusion Set, Half Set, SmartSite" Y-site REF: 24301-0007T, BD Alaris" Pump Infusion Set, SmartSite" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium" Closed Male Luer with Priming Cap, SmartSite" Y-site

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code FRN·July 8, 2025

    OPEN HEART TRAY PACK A CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) MAYO STAND COVER REINFORCED L/F (3) TOWEL ABSORBENT 15" X 20" LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SPLIT SHEET BILATERAL 84" X 80" (12) % SHEET 60" X 77" DRAPE REINFORCED LIF (1) MAYO TRAY LARGE (1) CV DRAPE SPLIT CARDIO WITH CLEAR ANEST. SC STD SMS (15) TOWELS CLOTH HUCK BLUE (4) TOWELS CLOTH HUCK WHITE (2) STOCKINETTE IMPERVIOUS 14" X 48" LIF (30) LAP SPONGE PREWASH 18" X 18" XRD LIF (1) WRAPPER 54" X 54" (3) LITES GLOVE LIF OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKB CONTENTS: (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (2) CATHETER THORACIC 32FR. STRAIGH (2) PENCIL CAUTERY ROCKER SWITCH LIF (3) TUBE SUCTION CONNECT W X 12' LIF (2) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) LABEL SET, HEPARINE SALINE (2) CAUTERY TIP POLISHER LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) BANDAGE ELASTIC 6" X 5yds LIF (2) YANKAUER SUCTION TUBE WITHOUT VENT LIF (2) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 25G X 5/8 ST. (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) NEEDLE HYPODERMIC 27G X %" ST. (1) NEEDLE & BLADE COUNTER 60C MAG/MAG (2) BOWL UTILITY 16oz. (4) FEEDING TUBE 8FR, 15" LONG (2) BULB SYRINGE 60cc (1) TRAY PLATFORM LARGE (1) SKIN MARKER WITH RULER (1) CATHETER 18FR SUCTION W/STRA LIF (1) WRAPPER 54" X 54" UF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (2) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #20 CARBON STEEL OPEN HEART TRAY HOSPITAL HERMANOS MELENDEZ PACKC CONTENTS: (9) TOWELS ABSORBENT 15" X 20" UF (6) GOWN FAB REINFORCED SONTARA X-LARGE (1) GOWN IMPERVIOUS XTRA REINFORCED X-LARGE TOWEL & WRAP LEVEL Ill (1) TABLE COVER REINFORCED 44" X 78" 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 OFA·May 20, 2014

    OPEN HEART TRAY - - PACK A ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF (5) DRAPE % ECONOMY 53" X 77" LIF ( 1) MAYO STAND COVER REINFORCED LIF (7) DRAPE UTILITY WITH TAPE L/F (8) HUCK CLOTH TOWELS WHITE L/F (20) HUCK CLOTH TOWELS BLUE LIF (1) MAYO TRAY LARGE LIF (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF (6) 3/4 SHEET DRAPE REINFORCED LIF (2) STOCKINETTE 9" X 48" LIF (1) SPLIT SHEET BILATERAL 84" X 80" LIF (3) DRAPE SHEET 41" X 58" SMS LIF (4) Pr. GLOVES SURGEON #7 BIOGEL OPEN HEART TRAY - HOSPITAL DAMAS - PACK B- (1) PLASTIC RULER 12" LONG (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F (1) Pk. PEANUT SPONGE DISSECTOR ST. (2) UTILITY BOWL 32 oz. LIF (1) SKIN MARKER WITH RULER LIF (2) UTILITY BOWL 16 oz. UF (3) BULB SYRINGE 60cc UF (1) MAYO TRAY SMALL L/F (2) YANKAUER SUCT. TUBE WITHOUT VENT UF (1) TRAY ORGANIZER FULL DEEP LIF (5) SAPHENOUS VEIN CANNULA LIF (40) LAP SPONGES PRE-WASH XRD UF (2) ELASTIC BANDAGE 6" X 5 yds. UF (2) SUTURE BAG FLORAL (2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF (1) BLADE SHARP ALL ARROUND 69 (1) SURGICAL BLADE# 11 CARBON STEEL (4) LITE GLOVES UF (2) SURGICAL BLADE# 15 CARBON STEEL (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF (2) POUCH INSTRUMENT (2) SURGICAL BLADE# 10 CARBON STEEL (30) GAUZE SPONGES 4" X 4" 16 PLY XRD UF (2) CAUTERY PENCIL ROCKER SWITCH LIF (2) POLISHER CAUTERY TIP UF (1) LABEL SET, HEPARINE,SALINE (2) ELASTIC BANDAGE 4" X 5 yds. LIF (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF (2) COTION GLOVE HEAVY DUTY (1) AORTIC MONITORING PRESS SET 5.0 (1) CONNECTOR Y 3/8" X 3/8" X 3/8" LIF (2) NEEDLE HYPODERMIC 22G X 1 % LIF (1) BLADE 6.1 X 32.3 X 1.0MM (1) SQUARE TWO PIECE 500cc GRADUATE (2) CONNECTOR REDUCER (1) NEEDLE BLADE/KNIFE 3.0MM 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 OFA·May 20, 2014

    The Verigene Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. The following virus types and subtypes are identified using the RV+: Influenza A, Influenza A subtype H1, Influenza A subtype H3, 2009 H1N1, Influenza B, Respiratory Syncytial Virus (RSV) subtype A, and RSV subtype B. The test is not intended to detect Influenza C virus. Detecting and identifying specific viral nucleic acids from individuals exhibiting signs and symptoms of respiratory infection aids in the diagnosis of respiratory viral infection, if used in conjunction with other clinical and laboratory findings. Negative results for Influenza A, Influenza B, or RSV do not preclude influenza virus or RSV infection and should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Conversely, positive results do not rule-out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. The use of additional laboratory testing and clinical presentation must be considered in order to obtain the final diagnosis of respiratory viral infection. Performance characteristics for Influenza A Virus were established when Influenza A/H3, A/H1, and 2009 H1N1 were the predominant Influenza A viruses circulating. These characteristics may vary when other Influenza A viruses are emerging. If infection with a novel Influenza A virus is suspected based on current clinical and epidemiological screening criteria recommended by public health authorities, specimens should be collected with appropriate infection control precautions used specifically for novel virulent influenza viruses and sent to state or local health department for testing. Viral culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

    FDA Recall
    Terminated ·Nanosphere, Inc.·Product code OCC·October 10, 2013

    Verigene Enteric Pathogens Nucleic Acid Test (EP) Model Number: 20-006-023

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·October 30, 2020

    Bentson PTFE Wire Guide, Guidewire, Global Product Number G14589, G14590

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

    FDA Recall
    Open, Classified ·Abbott Diagnostics Scarborough, Inc.·Product code OCC·March 4, 2025

    Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package contains 25 transport tubes). The Influenza Swabs in dry transport tubes are intended for use with influenza tests

    FDA Recall
    Terminated ·Quidel Corporation·Product code OCC·January 25, 2017

    cobas Liat Influenza A/B Quality Control Kit; For use with cobas Liat Influenza A/B Assay.

    FDA Recall
    Terminated ·Roche Molecular Systems, Inc.·Product code OCC·May 17, 2016

    VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OCC·December 10, 2018

    Heavy Duty PTFE Wire Guide, Guidewire, Global Product Number G14323 G14260 G14260

    FDA Recall
    Terminated ·Cook Inc.·Product code OCY·January 4, 2019

    Brand Name: ID NOW RSV 24T Product Name: ID NOW RSV 24T Model/Catalog Number: 435-000 Software Version: N/A Product Description: Respiratory virus panel nucleic acid assay system Component: No

    FDA Recall
    Open, Classified ·Abbott Diagnostics Scarborough, Inc.·Product code OCC·March 4, 2025