News

03 Aug 2016

CLH Blog - MHRA updates for July

Welcome to our fourth monthly medical field safety alerts blog, this time for the month of July. Once again we will be detailing healthcare product updates and alterations that are relevant for UK care homes and listed with the Medicines and Healthcare products Regulatory Agency (MHRA) amongst other suppliers.

July’s alerts:

• Baxter Healthcare Ltd: Vascu-Guard Peripheral Vascular Patch – RECALL
Baxter Healthcare Ltd has issued an alert regarding its Vascu-Guard Peripheral Vascular Patches, following reports there may be a risk attached with the product.
For more information about this alert and what action to take, please see here.

• Ellex: Integre-S serial numbers 5A2035 to 5A2137 – FIELD SAFETY ALERT
Ellex has issued an alert to highlight a possible defect with its Fixed Eye Safety Filters (serial numbers mentioned above), potentially leading to a dangerous reflected laser light into the eye of a patient.
For more information about this alert and what action to take, please see here.

• Hill-Rom: Progressa Bed (P7500) w/European Version Scale – MEDICAL DEVICE CORRECTION
Hill-Rom has identified that there may be an issue with how the air system utilises data from the scale to set bladder pressure points. This can result in incorrect bladder pressure for the patient.
For more information about this alert and what action to take, please see here.

• MicroPort Orthopedics: ADVANCE HA Coated Tibial Bases – FIELD SAFETY ALERT
MicroPort Orthopedics has initiated a voluntary Field Safety Corrective Action for the abovementioned product after discovering a potential fault with the implant loosening after fitting.
For more information about this alert and what action to take, please see here.

• Accu-Chek: Performa Nano Blood Glucose Monitoring Kits – PRODUCT REPLACEMENT
Accu-Check has found that in 1200 units from lots 10135127 and 10134053, the code key has not been pre-inserted, therefore making the product unable to operate.
For more information about this alert and what action to take, please see here.

• Macopharma: Bottom and Top (BAT) Systems – FIELD SAFETY ALERT
Macopharma has received reports that several of these products are missing the slits on the side and bottom of the product, meaning the product is not able to be hung up and utilised correctly.
For more information about this alert and what action to take, please see here.

• Smith & Nephew: Sterile RENASYS Transparent Film – RECALL
Smith & Nephew has identified seal integrity failures on the product above, potentially leading to a lack of sterility and a possible local infection when used.
For more information about this alert and what action to take, please see here.

Please note this is not a definitive list of field safety alerts, please visit the MHRA website for more.

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