BEUDAMED
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    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

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    FDA Enforcement
    Class II ·Terminated·Olympus Corporation of the Americas·August 14, 2019

    Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW

    FDA Enforcement
    Class II ·Terminated·GN Hearing A/S·December 4, 2019

    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

    Disposable Hemostasis Clip, DCH-7-230, Rx only, Single Use only, Cook Medical Product Usage: This device is used for endoscopic clip placement within the gastrointestinal tract for the purpose of endoscopic marking, hemostasis for mucosal sub-mucosal defects less thank 3cm in the upper GI tract, bleeding ulcers, arteries les than 2 mm, and polyps less than 1.5cm in diameter in the GI tract,. This device is not intended for the repair of GI tract luminal perforations.

    FDA Recall
    Terminated ·Cook Endoscopy·Product code MND·June 7, 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

    Human Lambda Free SPAPlus Kit Product Code: LK018.S Freelite aids in the detection and monitoring of Multiple Myeloma and related diseases.

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DEH·November 28, 2012

    Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DEH·October 15, 2021

    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

    Freelite Human Lambda Free Kit for use on SPAPLUS Product Code: LK018.S, LK018.10S Freelite aids the detection and monitoring of Multiple Myeloma and related diseases

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DEH·October 28, 2016

    Optilite Freelite Lambda Free Kit Product Code: LK018.OPT, LK018.OPT.A Protein testing kit.

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DEH·July 5, 2016

    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

    Custom convenience kits containing Medline brand Sterile Pre-Saturated Povidone Iodine Sponge Products, labeled as follows: Part Description Part Number ABDOMINAL HYSTERECTOMY DYNJ906478 ABDOMINAL HYSTERECTOMY DYNJ906478A ACCESSORY HIP PACK-LF DYNJ0781865M ARTHRO/SHOULDER PACK DYNJ30056J ARTHRO/SHOULDER PACK DYNJ30056K ARTHRO/SHOULDER PACK DYNJ30056L ARTHRO/SHOULDER PACK DYNJ30056M BODY PACK DYNJ55107A BODY PACK DYNJ55107C BODY PACK DYNJ55107D C SECTION CDS CDS984613D C SECTION CDS CDS830172I C SECTION CDS CDS984613F C SECTION CDS CDS830172J C SECTION PACK CMPJ17294I C SECTION PACK-LF DYNJ64834 CARDIAC A & B SJ PACK DYNJ0619768D CARDIAC PROCEDURE PACK DYNJ63700 CLOSURE CDS CDS983704D CLOSURE CDS CDS983704F CLOSURE CDS CDS983704G COLECTOMY LAPAROSCOPIC DYNJ906875 COLORECTAL ME DYNJ906437 CRANIOTOMY DYNJ905330A CRANIOTOMY DYNJ905330B C-SECTION PACK DYNJ32884F C-SECTION PACK DYNJ32884G C-SECTION PACK DYNJ32884I C-SECTION PACK DYNJ32884J C-SECTION TRAY DYNJ62707 CYSTO DYNJ901329B CYSTO DYNJ901608B CYSTO DYNJ903225I CYSTO CDS982015O CYSTO DYNJ903225J CYSTO CDS982015P CYSTO DYNJ903225K CYSTO DYNJ906481 CYSTO DYNJ903225L CYSTO CDS CDS985376C CYSTO CDS-LF CDS982481I CYSTO CDS-LF CDS982481J CYSTO CDS-LF CDS982481K CYSTO CDS-LF CDS982481L CYSTO PACK DYNJ05177G CYSTO PACK DYNJ51350A CYSTO PACK DYNJ37252F CYSTO PACK DYNJV0052L CYSTO PACK DYNJ37680D CYSTO PACK DYNJ58223 CYSTO PACK DYNJ53570A CYSTO PACK CMPJ01845I CYSTO PACK DYNJ37252G CYSTO PACK DYNJ37252I CYSTO PACK-LF DYNJ24911D CYSTO PACK-LF CMPJ02168J CYSTO PACK-LF DYNJ30470B CYSTO PACK-LF CMPJ02168K CYSTO PACK-LF DYNJ51350B CYSTO PACK-LF DYNJ51350C CYSTO TRAY-LF DYNJ42146A CYSTO/UROLOGY PACK DYNJ64197 CYSTO-LF DYNJ50098 CYSTOSCOPY-LF DYNJ22891I D&C HYSTEROSCOPY DYNJ901049B D&C HYSTEROSCOPY DYNJ901049C D&C HYSTEROSCOPY DYNJ901049D D&C HYSTEROSCOPY PACK CMPJ43148C D&C HYSTEROSCOPY PACK CMPJ43148D D&C HYSTEROSCOPY PACK CMPJ43148F D&C PACK DYNJ33603D D&C PACK DYNJ22567C D&C PACK DYNJ22567D D&C PACK DYNJ55814B D&C PACK-LF DYNJ22567F D&C/GYN-LF DYNJ61949 D&C/GYN-LF DYNJ61949A D&C-LF DYNJ50099A D&C-LF DYNJ906482 DELIVERY PACK SMMC-LF DYNJ35244D DELIVERY PACK SMMC-LF DYNJ35244F DENTAL ENT PACK-LF DYNJ43405B DR H PACK DYNJ62374 DR. S PACK DYNJ60499 EAR DYNJ906058A EAR DYNJ906058B EAR DYNJ906058F GEN PLASTIC DYNJ901298A GENERAL DELIVERY PACK-LF DYNJ15915F GENERAL PACK DYNJ37894B GENERAL PACK DYNJ61784 G S CYSTO PACK DYNJ62403 G CYSTO CDS CDS984190G G CYSTO CDS CDS984190I G CYSTO CDS CDS984190J G D & C CDS CDS984203F G D & C CDS CDS984203G G D & C CDS CDS984203I G D & C CDS CDS984203J G LASER VEIN CDS CDS984193M G LASER VEIN CDS CDS984193N G PELVISCOPY CDS CDS984187M G PELVISCOPY CDS CDS984187N G PELVISCOPY CDS CDS984187O G PELVISCOPY CDS CDS984187P G VAGINAL CDS CDS984201M G VAGINAL CDS CDS984201O G VAGINAL CDS CDS984201P G VAGINAL CDS CDS984201Q GU SEED PACK-RF-LF DYNJ01631F GU-GEN ROBOTIC PACK CMPJ11121 GYN LAPAROSCOPY DYNJ903869 GYN LAPAROSCOPY DYNJ901636B GYN LAPAROSCOPY DYNJ902101A GYN LAPAROSCOPY DYNJ37256D GYN LAPAROSCOPY DYNJ903869A GYN LAPAROSCOPY DYNJ903869B GYN LAPAROSCOPY DYNJ903869C GYN LAPAROSCOPY DYNJ903869D GYN LAPAROSCOPY CDS CDS983410C GYN LAPAROSCOPY CDS CDS985217D GYN LAPAROSCOPY CDS CDS983410D GYN LAPAROSCOPY CDS CDS985217F GYN LAPAROSCOPY CDS CDS983410F GYN LAPAROSCOPY CDS CDS985217G GYN LAPAROSCOPY PACK DYNJ48614C GYN LAPAROSCOPY PACK DYNJ22568F GYN LAPAROSCOPY PACK DYNJ22568G GYN LAPAROSCOPY PACK DYNJ37337G GYN LAPAROSCOPY PACK-LF DYNJ22568I GYN LAPAROSCOPY/LAVH CDS CDS981294C GYN LITHOTOMY PACK DYNJ48615B GYN ONCOLOGY ME DYNJ900201G GYN ROBOTIC DYNJ903282D GYN ROBOTIC DYNJ903282F GYN ROBOTIC DYNJ903282G GYN ROBOTIC DYNJ903282I GYN ROBOTIC DYNJ903282J GYN ROBOTIC DYNJ903282L GYN-URO LAPAROSCOPY DYNJ904856 GYN-URO LAPAROSCOPY DYNJ904856A HEAD AND NECK PACK DYNJ46509C HEART PACK A&B CMPJ22236V HH PAIN CLINIC PACK DYNJ59488 HMT CY

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·May 27, 2020