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    HemosIL LMW Heparin Controls; Part Number: 0020300200;

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·February 3, 2025

    HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic

    FDA Recall
    Open, Classified ·Instrumentation Laboratory·Product code KFF·December 18, 2024

    Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-10 mL vial; 25 pack, NDC 0641-2438-45, (NDC 0641-2348-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

    Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 units/mL-30 mL vial; 25 pack, NDC 0641-2442-45 (NDC 0641-2442-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

    Baxter HEP LOCK (Heparin Lock Flush Solution, USP) 10 u/mL-1mL vial, 25 Pack, NDC 0641-0392-25 (NDC 0641-0392-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

    Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-2 mL vial, 25 pack, NDC 0641-0387-25, (NDC 0641-0387-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

    Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack , NDC 0641-0389-25, (NDC 0641-0389-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

    Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-30 mL vial, 25 pack, NDC 0641-2443-45, (NDC 0641-2443-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

    Baxter HEP-LOCK (Heparin Lock Flush Solution, USP) 100 units/mL-10 mL vial, 25 pack, NDC 0641-2436-45, (NDC 0641-2436-41; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

    Baxter HEP-LOCK (Heparin Lock Flush Solution, USP), 10 u/mL-2 mL vial, 25 pack, NDC-0641-0393-25, (NDC-0641-0393-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

    Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 10 units/mL-1 mL vial, 25 pack, NDC 0641-0272-25 (NDC 0641-0272-21: on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

    Baxter HEP-LOCK (Preservative-Free Heparin Lock Flush Solution, USP) 100 units/mL-1 mL vial, 25 pack, NDC 0641-0273-25 (NDC 0641-0273-21; on vial), Baxter Healthcare Corporation, Deerfield, IL 60015

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code NZW·February 28, 2008

    Kallestad (TM) HEp-2 Cell Line Substrate. Product labeled "BIO-RAD Kallestad (TM) HEp-2 Cell Line Substrate... UNITED STATES, Bio-Rad Laboratories, Redmond, WA 98052... FRANCE, Bio-Rad Laboratories, 92430 Marnes La Coquette". Catalog #: 30471 - 12 well kit, 60 tests; 30472 - 12 well kit, 240 tests; and 32583 - 6 well kit, 48 tests.

    FDA Recall
    Terminated ·Bio-Rad Laboratories·Product code DBM·July 29, 2008

    Integra LifeSciences Corporation Disposable Convenience Kit, PICC Insertion Tray, CUS791

    FDA Recall
    Terminated ·Integra Pain Management·Product code FMF·March 18, 2008

    Brand Name: MEDLINE Product Name: SYR 20ML/L WHITE HEP FLUSH Model/Catalog Number: 91862 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Recall
    Open, Classified ·Jiangsu Shenli Medical Production Co., Ltd. No.·Product code FMF·April 5, 2024

    Brand Name: MEDLINE Product Name: SYR 10ML L/L YELLOW HEP/SALINE Model/Catalog Number: 91855 Product Description: NON-Sterile syringes without needles for single use Component: No

    FDA Recall
    Open, Classified ·Jiangsu Shenli Medical Production Co., Ltd. No.·Product code FMF·April 5, 2024

    8" Extension Set with SmartSite(TM) HEP-Lock and Rotating Luer Lock. SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FPA·February 1, 2010

    8" Microbore Extension with Detachable SmartSite(TM) HEP-Lock and Retractable Spinning Luerlock. DEHP-Free SmartSite(TM) is a trademark of Alaris Medical Systems, Inc. An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FPA·February 1, 2010

    Non-Vented IV Set with 2-Gang "Hi-Flo" Stopcocks with Luer Activated HEP Lock Valves and Luer Activated Y-Injection Sites. (Approx. 10 Drop/ML). An Intravenous Administration Tubing set is a device intended for medical purposes that consists of tubing and components with suitable adaptors used to transfer blood, plasma or intravascular fluids from a container to a patient's vascular system.

    FDA Recall
    Terminated ·Arrow International Inc·Product code FPA·February 1, 2010

    Quest EIA ANA Screen Bulk Kit, model number 96AN-BPU-QUEST. Manufactured by Bio-Rad Laboratories, Inc., Hercules, CA. For labeling and distribution by Quest International Inc. Medical device is used as a qualitative enzyme immunoassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA), histones, SS-A/Ro, SS-B/LA, Sm, Sm/RNP, Scl-70, Jo-1 and centromeric antigens along with sera positive for Immunofluorescent (IFA) HEp-2.

    FDA Recall
    Terminated ·Bio-Rad Laboratories Inc·Product code LKJ·February 26, 2010