BEUDAMED
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    3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product code 902150 (Kit- 112 crowns/kit) and 900114 (Refill- 5 crowns/box). Product Usage: Stainless Steel Crowns are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.

    FDA Recall
    Terminated ·Product code ELZ·August 5, 2013

    3M ESPE, Unitek Stainless Steel Permanent Molar Crowns Stainless Steel Crowns, are designed to fill the need for long term provisional coverage on adult molars and bicuspids as well as pediatric posterior and anterior teeth.

    FDA Recall
    Terminated ·3M Company Health Care Business 3M Center·Product code ELZ·June 5, 2013

    3M ESPE Stainless Steel Primary Molar Crowns, Made in USA by 3M ESPE Dental Products, St Paul, MN. Unitek" Primary Stainless Steel Crowns- Series UL3 and UR3 Product Code 900223, 900213, 902150

    FDA Recall
    Terminated ·Product code ELZ·October 6, 2010

    3M ESPE Unitek Stainless Steel Permanent Molar Crowns , Product Code: 900321, Made in U.S.A by 3M ESPE Dental Products St. Paul, MN 55144-1000.

    FDA Recall
    Terminated ·Product code ELZ·October 17, 2007

    AccuChek Spirit insulin infusion pump.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code LZG·April 22, 2015

    AccuChek Spirit Combo insulin infusion pump sold as part of Accu-Chek Combo System.

    FDA Recall
    Terminated ·Roche Diabetes Care, Inc.·Product code LZG·April 22, 2015

    LAPAROSCOPY CHOLECYSTECTOMY PACK- (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD UF (2) ABSORBENT TOWELS 15" X 20" UF (1) MAYO STAND COVER REINFORCED UF (4) BANDAGE ADHESIVE W' x 3" L I F (4) DRAPE UTILITY WIT APE UF (1) TUBE SUCTION CONNECT. Y..'' X 12' UF (1) INSUFLAT TUBING SET W/0 RING ADAPTOR UF (1) LAPAROSCOPY ABO. DRAPE W/Pouch UF (1) IMP. GOWN REINFORCED XLge. SMS (2) SYRINGE 60ML W/0 NDL. LILOCK UF (1) SYRNGE 20 cc W/0 NDL ULOCK UF (1) SURGICAL BLADE #15 C/STEEL (1) DRAPE LASER CAMERA W/EL (2) COVER HANDLE LITE LOCK (1) TABLE COVER Reinforced 50" x 90" UF (3) DRAPE SHEET 41 " x 58" SMS (1) SURG. GOWN REINFORCED T/Wrap Lge. 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 LRO·May 20, 2014

    EZ Derm Porcine Xenograft, labeled as the following: a. EZ Derm 3x4 (8x10 cm) Non-Perforated, Part Number: 131703-03; b. EZ Derm 7 x 18 (17 x 46 cm) Non-Perforated, Part Number: 131704-03; c. EZ Derm 2 x 2 (5 x 5 cm) Non-Perforated, Part Number: 131705-03; d. EZ Derm 3 x 48 (8 x 122 cm) Perforated, Part Number: 131710-03; e. EZ Derm 3 x 24 (8 x 61 cm) Perforated, Part Number: 131711-03; f. EZ Derm 3 x 12 (8 x 30 cm) Perforated, Part Number: 131712-03; g. EZ Derm 3 x 4 (8 x 10 cm) Perforated, Part Number: 131713-03; h. EZ Derm 7 x 18 (17 x 46 cm) Perforated, Part Number: 131714-03; i. EZ Derm 2 x 2 (5 x 5 cm) Perforated. Part Number: 131715-03 Product Usage: EZ Derm is a porcine derived xenograft in which the collagen has been cross linked with an aldehyde. EZ Derm (porcine xenograft) can be used for partial thickness skin loss injuries. Use of EZ Derm for burns, donor sites and chronic vascular ulcers reduces pain and fluid loss. EZ Derm can also be used as a temporary cover, or test graft, prior to auto grafting and as a protective covering over perforated auto grafts.

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·Product code KGN·March 26, 2019

    Sorin Paradym CRT-D Model 8750 and Sorin Group Paradym sonR CRT-D Model 8770. Made in Italy by Sorin Biomedical CRM S.r.l. Via Crescentino s.n. , 13040 Saluggia (VC) Italy

    FDA Recall
    Terminated ·ela Medical Llc·Product code NIK·June 7, 2010

    Alto MSP (model 617) and Alto 2 MSP (model 627) Implantable cardioverter Defibrillator. Ventricular antitachycardia pacing. Dual chamber arrhythmia detection. biventricular pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.

    FDA Recall
    Terminated ·ela Medical Llc·Product code MRM·July 19, 2005

    Alto VR (model 615) and Alto 2 VR(model 625) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Single chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.

    FDA Recall
    Terminated ·ela Medical Llc·Product code MRM·July 19, 2005

    Alto DR (model 614) and Alto 2 DR (model 624) Implantable cardioverter Defibrillator. Ventricular antichycardia pacing. Dual chamber arrhythmia detection. Antibradycardia pacing. ELA medical 98, rue Maurice Amoux, 92120 Montrouge- FRANCE. These ICDs are designed to recognize and treat slow or fast Ventricular Tachycardia or Ventricular Fibrillation by continuously monitoring atrial and ventricular activity to identify persistent ventricular arrhythmias and to deliver appropriate therapies.

    FDA Recall
    Terminated ·ela Medical Llc·Product code MRM·July 19, 2005

    Alto implantable cardioverter defibrillator

    FDA Recall
    Terminated ·ela Medical Llc·Product code LWS·October 21, 2004

    Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.

    FDA Recall
    Terminated ·ela Medical Llc·Product code LWS·January 25, 2005

    Sorin Group Reply DR Rate responsive dual-chamber pacemaker. Made in Italy by: Sorin BioMedica CRM S.r.l., Via Crescentino s.n., 13040 Saluggia (VC) Italy. ELA Medical, Inc., 14401 West 65th Way, Arvada, CO 80004, USA. REPLY DR is a DDDR-type dual-chamber rate-responsive pacemaker. It is equipped with a physiological sensor and an accelerometer to allow adaptation of pacing to suit the patient's activity. The REPLY device can be programmed to separate pacing and sensing polarities, independent of chamber.

    FDA Recall
    Terminated ·ela Medical Llc·Product code NVZ·September 23, 2008

    Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.

    FDA Recall
    Terminated ·ela Medical Llc·Product code LWS·January 25, 2005

    ELA Rhapsody SR model 2210. A single chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.

    FDA Recall
    Terminated ·ela Medical Llc·Product code DXY·October 25, 2005

    Paradym DR Model 8550 and Paradym VR Model 8250, Sterile EO, Manufactured in Italy by Sorin CRM S. r.l., Via Crescentino s.n., 13040 Saluggia(VC) Italy PARADYM DR 8550 and PARADYM VR 8250 are indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent, poorly tolerated sustained ventricular tachycardia (VT).

    FDA Recall
    Terminated ·ela Medical Llc·Product code MRM·May 2, 2011

    Symphony DR model 2550 and ELA Rhapsody DR model 2510. A dual chamber rate-responsive pacemaker that uses both minute ventilation and accelerometer sensors. Sterilization with Ethylene Oxide Gas. Sorin Group, ELA medical, 98, rue Maurice Amoux, 92120 Montrouge - France. Made in France.

    FDA Recall
    Terminated ·ela Medical Llc·Product code DXY·October 25, 2005

    Forteo [teriparatide (rDNA origin) injection] black starter kits containing Triad alcohol pads. The starter kits look like insulated lunch boxes and contain alcohols pads, needles, instruction guides, and freezer gel packs. Note: the kits do not contain the drug, Forteo. Intended use: Travel starter kits to hold the drug Forteo and supplies needed to deliver the subcutaneous injection.

    FDA Recall
    Terminated ·Eli Lilly and Company·Product code KMJ·March 17, 2011