BEUDAMED
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    Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·October 15, 2021

    Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·October 15, 2021

    Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10444801(US) and 10444802 (OUS)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 8, 2021

    Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·December 8, 2021

    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·January 25, 2017

    Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural

    FDA Recall
    Terminated ·CareFusion 303, Inc.·Product code FRN·December 2, 2016

    Pro 2000, Alternating Pressure Air Flotation Mattress, Model number 5613 Designed to provide enhanced static and pulsation pressure relieving therapies.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Synergy Air Squared, Alternating Pressure Air Flotation Mattress, Model number 6361. Designed to prevent and treat decubitus ulcers. This is accomplished by achieving interface pressures well below capillary closure during the alternation cycle.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Synergy Pulse, Powered Flotation Therapy bed, Model number 5609. Designed to provide enhanced static and pulsation pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing pulsation therapy.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Synergy Dynamic, Powered Patient Rotation Bed, Model number 5607. Designed to provide enhanced static, pulsation and rotational pressure relieving therapies. Provides sixteen pressure zones for customizing the support surface to each patient, and is capable of providing alternating pressure therapy and lateral rotation up to 45 degrees side to side.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code FNM·October 9, 2008

    Boston Scientific, Flexima and Percuflex Drainage Catheter Family (Pigtail Style) UPN DESCRIPTION M001271540 FLEXIMA BILIARY FIRM 8F/35CM M001271550 FLEXIMA BILIARY FIRM 10F/35CM M001271560 FLEXIMA BILIARY REG 8F/35CM M001271570 FLEXIMA BILIARY REG 10F/35CM M001271580 FLEXIMA BILIARY REG 12F/35CM M001271590 FLEXIMA BILIARY REG 14F/35CM M001271600 FLEXIMA BILIARY SOFT 10F/35CM M001271610 FLEXIMA BILIARY SOFT 12F/35CM M001271620 FLEXIMA BILIARY SOFT 14F/35CM M001281560 FLEXIMA BILIARY 8/35 TT M001281570 FLEXIMA BILIARY 10/35 TT M001281580 FLEXIMA BILIARY 12/35 TT M001281590 FLEXIMA BILIARY 14/35 TT M001271630 FLEXIMA BIL 8F/35CM FIRM KIT M001271640 FLEXIMA BIL 10F/35CM FIRM KIT M001271650 FLEXIMA BIL 8F/35CM REG KIT M001271660 FLEXIMA BIL 10F/35CM REG KIT Single Use Only, Sterilized with Ethylene Oxide Gas, Boston Scintific Corporation, One Boscton Scintific Place, Natick, MA 01760-1537, Made in USA 780 Brookside Drive, Spencer, IN 47460 1080. Designed for percutaneous drainage of abscess fluid, the Biliary system and the urinary tract.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FFA·March 18, 2009

    Hill-Rom brand Resident LT bed ambulatory assist bar accessory; accessory P865A.

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code KMM·November 14, 2003

    Hill-Rom Affinity 4 Birthing Bed; Model P3700B, Hill-Rom, Inc., Batesville, IN 47006

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code HDD·September 6, 2007

    FLEXICAIR MC3 Low Airloss Therapy unit

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·August 27, 2003

    FLEXICAIR II, Low Airloss Therapy unit.This unit is similar to MC3 but does not have the utility shelf above the foodboard, patient scale or alternate CPR function actuators.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·August 27, 2003

    Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company. Enables a comfortable sitting position and adapts to the patient without the need for individual adjustments when transferring a patient with a lift.

    FDA Recall
    Terminated ·Hill-Rom, Inc. 125 E Pearl St 1069 State Route 46 East Batesville IN 47006·Product code FSA·February 9, 2011

    LIFECATH S PICC Catheter, Percutaneous, Intravascular Product Code 2296.211 Product Usage:: Intravascular catheter

    FDA Recall
    Terminated ·Vygon Corporation·Product code LJS·April 26, 2011

    LIFECATH S PICC with Microflash Introducer Catheter, Percutaneous, Intravascular Product Code 2296.214 Product Usage: Intravascular catheter

    FDA Recall
    Terminated ·Vygon Corporation·Product code LJS·April 26, 2011

    Affinity Four Birthing Bed Model P3700 The primary packaging is pictured below, and utilizes a metal packing brace, standard corrugated cardboard and plastic banding. When possible these beds are shipped as a quantity of two (2) together as shown with the nylon strapping. These are shipped in standard freight containers. There is no secondary packaging.

    FDA Recall
    Terminated ·Hill-Rom, Inc.·Product code KNC·July 15, 2016

    Baxter Colleague CX and CXE Infusion Pumps, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8161 and 2M9161. Intended for use in a wide variety of patient environments for adult, pediatric and neonatal patients.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FRN·December 1, 2010