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    FC4000 MicroTargeting Electrode Kit 5x For use with Nexframe and Nexdrive Distributed by Medtronic Inc., Minneapolis, MN REF: FCH 4000 (5 Prefilled single use kits -5 packages and 2 electrodes each) Intended for use in intra-operative recording of single unit neuronal activity or intra-operative stimulation of neural elements in the brain.

    FDA Recall
    Terminated ·FHC, Inc.·Product code GZL·October 20, 2008

    ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8001; Individually Packaged Kit, Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WI The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing.

    FDA Recall
    Terminated ·Immunetech Inc·Product code JKA·November 4, 2011

    ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8021, Screening Pack: 100 test (with lancet & capillary), Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WI The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing.

    FDA Recall
    Terminated ·Immunetech Inc·Product code JKA·November 4, 2011

    ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8015, Screening Pack: 50 test (with lancet), Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WI The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing.

    FDA Recall
    Terminated ·Immunetech Inc·Product code JKA·November 4, 2011

    ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8014, Provider Pack: 10 test (without lancet), Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WI The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing.

    FDA Recall
    Terminated ·Immunetech Inc·Product code JKA·November 4, 2011

    ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8013, Provider Pack: 10 test (with lancet), Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WI The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing.

    FDA Recall
    Terminated ·Immunetech Inc·Product code JKA·November 4, 2011

    ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No. 8024, Provider Pack: 5 test, Product is manufactured distributed by ImmuneTech, Inc., Foster City, CA; but the non-sterile alcohol prep pads are manufactured by H & P Industries, Inc., Triad Group, Hartland, WI The MyAIIergyTest is for the collection and transport of a capillary blood sample to a clinical laboratory for allergen specific lgE profile testing.

    FDA Recall
    Terminated ·Immunetech Inc·Product code JKA·November 4, 2011

    Custom Dialysis prep kits labeled as follows: ADV-CARE-ISL44, 100/CS, LOT #K1018, EXP 5-12, BIN 34B; COMMUNITY-CATH, 150/CS, LOT #K1052, EXP 5-12, BIN 36B; COLUMBUS-CATH, 50/CS, LOT #1080, EXP 05-12, BIN 39B; RENALSG-CATH, 75/CS, LOT #L1046, EXP 6-12, BIN 40B; SUNYDOWN-HEMO, 100/CS, LOT #l1015, EXP 6-12, BIN 28A; KIDNEYCARE 125/CS, LOT #l1070, EXP 6-12; METHODIST-CATH, 75/CS, LOT #L1072, EXP 6-12; METHODIST-HEMO, 150/CS, LOT #L1073, EXP 6-12; MERCYMED-CATH, 75/CS, LOT #L1077, EXP 6-12, BIN 39A and SANTACLA-CATH, 75/CS, LOT #A1118, EXP 7-12, BIN 44A. Product Usage: custom dialysis prep kits

    FDA Recall
    Terminated ·Lee Medical International Inc·Product code FKG·August 15, 2011

    Disposable Water Trap with ''T'' for Ventilator Circuits; product reorder 6090; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

    FDA Recall
    Terminated ·Medex Inc·Product code BYH·July 12, 2004

    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012

    Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    FDA Recall
    Terminated ·Custom Healthcare Systems, Inc.·Product code FCH·November 26, 2012

    Disposable Water Trap with ''Y'' for Ventilator Circuits; product reorder 6091; SIngle Patient Use only; IPI label - Manufactured by IPI Medical Products, 3217 N. Kilpatrick St., Chicago, IL 60641and Medex label - Manufactured by Medex, Carlsbad, CA 92008

    FDA Recall
    Terminated ·Medex Inc·Product code BYH·July 12, 2004

    Core Biopsy Tray Catalog Number: 8673R4

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FCH·February 22, 2022

    Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner, Part Number 740-0322, Lot Number 2792584, Ormco Corporation, Glendora, CA 91740

    FDA Recall
    Terminated ·Ormco Corporation·Product code DYH·October 31, 2007

    BREAST PACK, Surgical Instrument Tray, REF/Catalog No. 5406, STERILE, Rx Only -- busse Hospital Disposables Hauppauge, NY --- Device Listing # E193298.

    FDA Recall
    Terminated ·Robert Busse & Co. Inc. d.b.a. Busse Hospital Disposables·Product code FCH·November 15, 2016

    Stereo Breast Biopsy Tray Catalog Number: 2383R1

    FDA Recall
    Terminated ·Busse Hospital Disposables, Inc.·Product code FCH·February 22, 2022

    Custom dialysis prep kits labeled as follows: KIDNEYCARE, 125/CS, LOT #A1160, EXP 7-12, BIN 35A, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #B1113, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-MT-POCONO-H, 200/CS, LOT #B1123, EXP 8-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-CATH-ISL44, 100/CS, LOT #B1127 EXP 8-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 ADV-HEMO-15G, 100/CS, LOT #B1128, EXP 8-12, BIN 34A, Lee Medical International, Inc., New Orleans, LA 70123 NORTHHUDSON-C, 100/CS, LOT #B1134, EXP 8-12, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 NORTHHUDSON-H, 75/CS, LOT #B1135, EXP 8012, BIN 42B, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-HEMO, SMALL GLOVES, LOT #B1143, B1144, and B1145. EXP 8-12, 100/CS, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-HEMO, MEDIUM GLOVES, LOT #B1146 and B1147, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-SUB, SMALL GLOVES, 100/CS, LOT #B1148, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 JOHNHAYES-SUB, SMALL GLOVES, LOT #B1149, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 SNCH-CATH, 50/CS, LOT #B1152, EXP 8-12, BIN 43A, Lee Medical International, Inc., New Orleans, LA 70123 COMMUNITY-HEMO, 125/CS, LOT #B1156, EXP 8-12, Lee Medical International, Inc., New Orleans, LA 70123 FLAMS-HEMO, 125/CS. LOT #B1162, EXP 8-12, BIN 38B, Lee Medical International, Inc., New Orleans, LA 70123 KINDEYSPA-HEMO, 125/CS, LOT #B1161, EXP 8-12, BIN 35B, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-H, 500/CS, LOT #C1107, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-CATH, 75/CS, LOT #C1108, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 DAV-MT-POCONO-H, 200/CS, LOT #C1109, EXP 9-12, BIN 45B, Lee Medical International, Inc., New Orleans, LA 70123 MESCALERO-HEMO, 200/CS, LOT #C1110, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 KIDNEYTRMT-HEMO, 125/CS, LOT #C1112 and C1123, EXP 9-12, BIN 45A, Lee Medical International, Inc., New Orleans, LA 70123 DAV-POCONO-H, 500/CS, LOT #C1126, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 METHODIST-HEMO, 150/CS, LOT #C1139, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 KINGMAN-HEMO, 150/CS, LOT #C1141, EXP 9-12, Lee Medical International, Inc., New Orleans, LA 70123 DAV-PALMERTON-H, 200/CS, LOT #C1145, EXP 9-12, BIN 43B, Lee Medical International, Inc., New Orleans, LA 70123 EMANUEL-CATH, 100/CS, LOT #C1146, EXP 9-12, BIN 34B, Lee Medical International, Inc., New Orleans, LA 70123 Product Usage: custom dialysis prep kits

    FDA Recall
    Terminated ·Lee Medical International Inc·Product code FKG·March 22, 2011