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Displaying 1 - 15 of 3472 items.
Bio-Rad Laboratories would like to inform you that our polyclonal blood grouping reagent Anti-Lua (LU1) (Catalogue number 808216, Lots 3131020-00 and 3131030-00) shows a decrease in reactivity with erythrocytes with low antigenicity. This may…
RecallHealth product recall | 2022-05-26
On 03/17/2022, a Stryker spine operator packaging non-sterile Yukon Straight Rods from finished goods inventory discovered a Yukon Straight Rod 120 mm (cat#7601-540120, lot# pcmw) with orange and white discoloration on the surface of the device.…
RecallHealth product recall | 2022-05-23
After initiating testing by a third-party lab, it was discovered that the tested lots did not meet the astm d6319 standard for medical gloves. Initial testing was received on March 4, 2022 and communicated to the original manufacturer. Confirmatory third…
RecallHealth product recall | 2022-05-20
GE Healthcare has become aware of two potential issues where inaccurate distance and area measurements can be displayed.
Recall start date: May 5, 2022
RecallHealth product recall | 2022-05-16
Potential for blood leak to occur with the anti-reflux valve upon treatment completion.
Recall start date: May 5, 2022.
RecallHealth product recall | 2022-05-16
The Carescape Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. Patient monitoring at the bedside is not affected.
Recall start date: May 10,…
RecallHealth product recall | 2022-05-16
The recall activities are being conducted due to several temperature excursions on inbound shipment to Canada. According, to the assessment by the manufacturer, Anteis S.A, no data is available for Belotero products after repeated freezing and…
RecallHealth product recall | 2022-05-16
August 25, 2019
For immediate release
OTTAWA – Health Canada is reminding Canadians that plasma pens are not authorized for sale in Canada and that these devices may pose health risks. Health Canada is also underlining that consumers should be wary…
AlertInformation update | 2022-05-11
November 26, 2018
For immediate release
OTTAWA – Health Canada is advising consumers that plasma pens (also known as “fibroblast” devices) promoted for cosmetic skin treatments such as eyelid lifts, wrinkle reduction and…
AlertInformation update | 2022-05-11
Manufacturer has received reports of events related to airway obstruction while using the impacted device. Not following the instructions for use (IFU) and over-inflating the cuff increases intra-cuff pressure, which can cause the silicone cuff to extend…
RecallHealth product recall | 2022-05-10
Dräger has become aware of one case in which an obstructed Breathing System Filter Safestar 55 was used on a patient during anesthesia. The patient reportedly became hypoxic and had to be reanimated. If an obstructed filter is used on a patient,…
RecallHealth product recall | 2022-05-10
During global post market surveillance activities cases have been reported that the sampling pump 6873493 shows a changing characteristic with increasing operating time, which can lead to the deactivation of the gas measurement during operation. The…
RecallHealth product recall | 2022-05-10
Since Nov. 2020, Arjo has become aware of 2 customer complaints involving overheating of metal part of the device located underneath its frame. The part involved is referred to as the e-bay box. No adverse health consequences (including temporary or…
RecallHealth product recall | 2022-05-10
During continuous post market surveillance, Draeger gathered information and market feedback indicating that there is a need to provide additional information in the instructions for use regarding the potential of the user to incorrectly position the…
RecallHealth product recall | 2022-05-10
COMIRNATY received a Notice of Compliance (NOC) under the Food and Drug Regulations on September 16, 2021, replacing the previous authorization under the Interim Order.
On March 15, 2022, COMIRNATY also received a NOC for an additional formulation…
AlertHealth professional risk communication | 2022-05-09