Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
ðĨ
Medical Devices Recalls
Medical equipment, implants, and diagnostic devices
38,779 Total Recalls
Class I - Dangerous
Six (6) PCA 10 Degree Hooded Acetabular Insert-Duration 22 mm (ID) have been distributed in the US, although the 22 mm size was inadvertently omitted from 510(k) #K963612.
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
During a review of the IFU of the SilverStat Pads, it was found that the IFU did not match that submitted in the original 510k
Fresenius 132 Gallon GranuFlo Dissolution Unit - P/N G047-80101. For Use in the Preparation of acid concentrate for hemodialysis.
Fresenius Medical Care Renal Therapies Group
Class I - Dangerous
Dissolution units and replacement motors units do not provide full thermal protection for both the Main and Starter coils resulting in the generation of smoke and/or potentially lead to fire.
Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.
Precision Medical
Class I - Dangerous
These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25).
Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.
Baxter Healthcare
Class I - Dangerous
Loud operating sounds, which was unacceptable to the end users when the device was powered on. The HomeChoice devices continue to perform as intended, as the issue is only associated with the noise coming from the device and not the function of it. May delay treatment if changing to a different system.
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class I - Dangerous
Hill-Rom is voluntarily recalling the Hill-Rom 100 Low Bed due to complaints of patient injury when exiting the beds set at the lowest position setting.
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Class I - Dangerous
Instances of data sets not being accurately registered to the patient anatomy were observed.
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
GMK Hinge knee prosthesis; Model Number: 02.09.TA410; Orthopedics and Orthopedic Surgery
Medacta Usa
Class I - Dangerous
Incorrect parts: Packages of the GMK Hinge Tibial Augmentation size 4-10 mm have 5 mm screws instead of 10 mm screws.
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.
ECG Out Cable,for use with a Philips ALS monitor/ defibrillator and bedside monitor for Synchronized cardioversion and Transcutaneous pacing. M1783A/M5526A 12-pin Sync cables, used with HeartStart MRx and HeartStart XL and HeartStart XL+
Philips Electronics North America
Class I - Dangerous
When a Philips monitor/defibrillator is receiving an ECG signal from an auxiliary bedside monitor via a sync cable, the following can occur if the monitor/defibrillator experiences interference from electrical fast transients (EFTs) while connected to AC power: On the HeartStart MRx and HeartStart XL, EFT noise can be misinterpreted as an R-wave. On the HeartStart XL+, EFT noise can disable ECG monitoring, and potentially interrupt demand mode pacing.
Class I - Dangerous
The lot number on the outer carton label did not match the lot number printed on the tray label or identification labels inside the box. The identification labels inside the box are placed on medical records and other documents associated with the procedure. Use of incorrectly identified labels may prevent direct traceability of the implanted unit in the future.
Bulk Loader Module for cobas p 512/612 Pre-analytical sample handling that includes de-capping, aliquoting and sorting of samples for analysis. In vitro diagnostic machine component.
Roche Diagnostics Operations
Class I - Dangerous
Possible for sample tubes in the loader to be opened and contaminate the system as well as adjacent samples during processing.
Ameditech is recalling drug abuse tests because they have shown reduced reactivity.