34 results
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15ms
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Sources: EU EUDAMED, US FDA
Puritan Bennett 700 Series Ventilators (PB740 and PB760) PB700 Series Operators Manual: PN 10066984 & PN G-061874-00 and PB700 Series Service Manual: PN 10070389 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code CBK·January 25, 2013
Puritan Bennett 840 Series Ventilator PB840 Operators Manual Addendum PN 066009A 09/02 The intended use of the oxygen sensor is to provide the oxygen concentration of the delivered gas at the patient wye (inspiratory-expiratory interface). The oxygen sensor does not control the oxygen level or the flow of gases. The intended use of the devices is as critical care ventilators that provide continuous mechanical ventilation for patients.
FDA Recall
Terminated
·Nellcor Puritan Bennett Inc. (dba Covidien LP)·Product code CBK·January 25, 2013
ARCHITECT STAT Myoglobin Calibrators; list 02K43-01; each kit contains 6 bottles of calibrators ranging from 0 ng/mL to 1200 ng/mL; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories MPG·Product code DDR·October 17, 2005
The product is the "FASTx Sternal Intraosseous Device". The expiration date for the recalled products is end of June, 2012. The device is used to insert an infusion tube into the manubrium (upper portion of the sternum) of a patient. It is intended for intraosseous infusion as an alternative to intravenous access, to facilitate emergency resuscitation through the use of drugs and fluids. It is indicated for use in establishing a sternal intraosseous access route in adult and adolescent patients (12 years of age and older) requiring vascular administration of drugs or fluids to facilitate emergency resuscitation.
FDA Recall
Terminated
·Pyng Medical Corporation·Product code FMI·November 5, 2010
IMx Tacrolimus II Calibrators, list 3C10-10; the pack contains six 4.5-mL bottles, with Calibrator A having 0 ng/mL, Calibrator B having 3 ng/mL, Calibrator C having 6 ng/mL, Calibrator D having 12 ng/mL, Calibrator E having 20 ng/mL and Calibrator F having 30 U/mL; Abbott Diagnostics, a Division of Abbott Laboratories, Abbott Park, IL 60064
FDA Recall
Terminated
·Abbott Laboratories HPD/ADD/GPRD·Product code MLM--·September 19, 2003
Abbott AxSYM Cancer Assay Disk Version 5.0, for in vitro diagnostic use with the AxSYM System; Abbott Laboratories, Abbott Park, IL 60064; List Number 3D50-05. AxSYM AFP is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of alpha-fetoprotein (AFP).
FDA Recall
Terminated
·Abbott Laboratories·Product code LOJ·February 20, 2009
IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JLS·July 10, 2019
IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US: 10901873, 10901874 and OUS 10381181, 10381170
FDA Recall
Terminated
·Siemens Healthcare Diagnostics, Inc.·Product code JLS·July 10, 2019
MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs
FDA Recall
Terminated
·Pyng Medical Corporation 210-13480 Crestwood Pl Richmond Canada·Product code GAX·August 31, 2015
Braun wheelchair lift, model NL, Braun Corporation, Winamac, IN A wheelchair lift for motor vehicles.
FDA Recall
Terminated
·The Braun Corporation·Product code ING·August 15, 2007
UNO 100 EM/EE Patient Lift
FDA Recall
Terminated
·Liko, Inc.·Product code FNG·September 24, 2004
Penner Manufacturing Patient Transfer/Lift System, Cascade Transfer, Models 380000-1 (white) and 380000-2 (gray). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Penner Manufacturing Transfer Electric Pacific Chair with scale, Patient Transfer/Lift System, Models 394000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Penner Manufacturing Bariatric Patient Transfer/Lift System, Cascade Transfer, Models 382500-1 (right entry). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Braun wheelchair lift, model NVL, Braun Corporation, Winamac, IN A wheelchair lift for motor vehicles.
FDA Recall
Terminated
·The Braun Corporation·Product code ING·August 15, 2007
Penner Manufacturing Transfer Electric Pacific Chair, Patient Transfer/Lift System, Models 393000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Penner Manufacturing Transfer Electric Superior end entry with scale, Patient Transfer/Lift System, Models 389000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Penner Manufacturing Transfer Electric Superior end entry, Patient Transfer/Lift System, Models 386000-1. The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009
Sabina I and II EM/EE Patient Lift
FDA Recall
Terminated
·Liko, Inc.·Product code FNG·September 24, 2004
Penner Manufacturing Transfer Electric Bariatric with Scale, Patient Transfer/Lift System, Cascade Transfer, Models 383500-1 (right entry with scale). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursing homes, hospitals, and assisted living facilities to transfer or lift patients under the direct supervision of trained staff.
FDA Recall
Terminated
·Penner Mfg Inc·Product code FNG·January 19, 2009