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    ORIGIO MIDATLANTIC DEVICES CRYOPETTE (r) Rx only Single use only CRY-PETTE-CL LOT 123456 2013-10-10 Exp. date *** MADE IN THE USA STERILE R ***Origio, Inc. 3400 Hunter's Way, Charlottesville, VA 22911 www.origio.com The Cryopette (r) is a cryopreservative storage device that is intended for use in vitrification procedures to contain and maintain human blastocyst stage embryos.

    FDA Recall
    Terminated ·ORIGIO HUMAGEN PIPETS INC.·Product code MQK·November 28, 2011

    Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL

    FDA Recall
    Terminated ·ORIGIO, Inc·Product code MQK·June 20, 2014

    ESSENTIAL MEDICAL SUPPLY, INC. ENDURANCE HD, BUILT TO LAST, HEAVY DUTY FOUR WHEEL WALKER for users up to 500 pounds. Model W1801B- Blue, UPC 7 54756 91802 6 all serial numbers. W1801R-Red, UPC 7 54756 91803 3 all serial numbers. The Endurance HD is a four wheeled steel frame walker with loop locking wheel locks, a padded seat and an under seat tote for carrying personal articles. Used to assist in ambulation and specifically for obese patients weighing up to 500 pounds. Warranty Card: "...lifetime of the original purchaser...". Usable life of a walker is 5 years but firm will warranty for lifetime of the original purchaser.

    FDA Recall
    Terminated ·Essential Medical Supply, Inc.·Product code ITJ·December 21, 2009

    O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 12KPES SIZE: 12Fr Product No: AAM 8012KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 12KPES Product No: AAM 8012KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.

    FDA Recall
    Terminated ·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011

    O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 10KPES SIZE: 10Fr Product No: AAM 8010KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 10KPES Product No: AAM 8010KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.

    FDA Recall
    Terminated ·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011

    O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 8KPES SIZE: 8Fr Product No: AAM 8008KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 8KPES Product No: AAM 8008KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.

    FDA Recall
    Terminated ·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011

    O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 14KPES SIZE:14Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 14KPES Product No: AAM 8014KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.

    FDA Recall
    Terminated ·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011

    O'Neil Sterile Field Intermittent Urinary Catheter Kit labeled in mart:"***ORIGINAL CLOSED SYSTEM BY DR O'NEIL O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER KIT WITH IODINE SWABSTICKS (3)*** REF: ONSM 16KPES SIZE:16Fr Product No: AAM 8014KPES***SINGLE USE ONLY***Original design by: Dr. George O'Neil 200 Churchill Ave, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 European Representative: Advena Ltd Hereford, HR4 9DQ, UK DISTRIBUTED IN THE USA BY: American Australian Medical, Inc. 1-888-880-8871***" Case of Catheter Kits labeled in part:"***The O'Neil Sterile Field Urinary Catheter Kit REF: ONSM 16KPES Product No: AAM 8016KPES***CAUTION: Federal law restrict sale of this device to or on the order of a physician. STERILE Single use only***Designed by: GO MEDICAL INDUSTRIES PTY LTD 200 Churchill Avenue, Subiaco, WA 6008, Australia Tel.: +61 (0)8 9388 1700 Fax: +61 (0)8 9382 4952 email: [email protected] Website: www.gomedical.com.au***Distributed in the U.S.A. by: AMERICAN AUSTRALIAN MEDICAL INC. BUFFALO, NY 14209 USA TEL: 1-888-880-8871***Country of Origin: ROMANIA***QUANTITY 50***" This kit includes a Urinary Catheter and accessories including gloves, tissue, underpads, and Triad Povidone Iodine Swabsticks (3). These accessories are included in the kit as optional and are not required for urinary catheterization.

    FDA Recall
    Terminated ·Go Medical Industries Pty., Ltd. 200 Churchill Avenue Subiaco Perth, Western Australia Australia·Product code FCM·September 3, 2011

    Obwegeser Ramus Clamp w/ wide shield, 20 cm, 8", Right. ORAL-MAXILLO-CRANIO-FACIAL SURGERY, Original OBWEGESER Instruments. Walter Lorenz Surgical, Inc., Subsidiary of Biomet Microfixation, Inc. NOTE: None distributed domestically. Cranio-maxillofacial manual instrumentation to be used to aid in the treatment and care of patients, as determined appropriate, by a trained medical professional. The Obwegeser Ramus Clamps are self-retaining clamps, used on the ascending ramus of the mandible with an extension on one of the blades (shields) to aid in retracting the soft tissue of the cheek.

    FDA Recall
    Terminated ·Biomet Microfixation, Inc.·Product code EMG·May 21, 2008

    MinXray P200R24 Stationary Podiatry X-Ray System, Model PS200+, MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A.

    FDA Recall
    Terminated ·Minxray Inc·Product code DS-22·June 29, 2004

    MinXray P200R40 Mobile Podiatry X-Ray System, Model PM200R40 (mobile) and PW200R40 (wall mounted), MinXray, Inc., 3611 Commercial Avenue, Northbrook, Illinois 60062-1822 U.S.A.

    FDA Recall
    Terminated ·Minxray Inc·Product code DS-21·June 29, 2004

    Original M.E. Mueller" Low Profile Cup Sterile, Rx

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JDI·September 4, 2012

    life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium Sulfur Dioxide, OEM P/N: 9146-001, voltage 12V, 7.5 amps, Mfg for Battery Zone, Inc ; Mfg by Nordix, Inc.

    FDA Recall
    Terminated ·BatteryZone, Inc.·Product code MKJ·August 24, 2007

    life+cel, Replacement battery for Cardiac Science FirstSave Survivalink,Lithium Sulfur Dioxide, Voltage 12V, 7.5 Amps.,OEM P/N: 9141-001,Mfg for Battery Zone, Inc; Mfg by Nordix, Inc.

    FDA Recall
    Terminated ·BatteryZone, Inc.·Product code MKJ·August 24, 2007

    Orthopedic manual Surgical Instrument handle for Simple Locking Intra Medullary (SLIM) System - Product Usage: The SLIM handle is the grip for the SLIM driver in orthopedic surgical procedures.

    FDA Recall
    Terminated ·Pega Medical Inc. 1111 Chomedey (A-13) E Laval Canada·Product code LXH·April 3, 2020

    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L74, Exu-Dry Sheet 36"x72" Permeable with Straps Quilted, Smith & Nephew, Inc.,Largo, Florida.

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code MCY·November 21, 2007

    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999018, Exu-Dry Dressing, 15" x 18", Smith & Nephew, Inc.,Largo, Florida.

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code MCY·November 21, 2007

    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LV1, Exu-Dry Large Burn Vest, Smith & Nephew, Inc.,Largo, Florida

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code MCY·November 21, 2007

    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M28, Exu-Dry Dressing, 15" x 28", Smith & Nephew, Inc.,Largo, Florida.

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code MCY·November 21, 2007

    Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L72,Exu-Dry Sheet 36"x72" Non-Permeable, Smith & Nephew, Inc.,Largo, Florida

    FDA Recall
    Terminated ·Smith And Nephew, Inc. Wound Management Division·Product code MCY·November 21, 2007