T + T – normal size
The Ministry of Health and Community Protection warned against the operations of two medical facilities, which have manufacturing problems, that may cause health damage to patients, and may lead to death, and demanded that they be withdrawn from the market and not be used.
In detail, the Ministry of Health and Community Protection warned all health facilities and health care practitioners against operating the medical device, “Safe Star 55 Breathing System Filters”, which is used as a filter for the breathing system, which is used as part of the ventilator when the patient is under anesthesia or needs To help with breathing.
The batch that suffers from a defect carries the number “LT2103”, for the model number “MP01790”, while the rest of the batches do not suffer from any technical problems.
The ministry stated that the reason for the withdrawal comes after the manufacturer withdrew a batch of the aforementioned medical device, due to a partial malfunction in some filters, as if the filter on the ventilator or breathing system becomes clogged, oxygen may not flow properly to the patient, causing Lack of oxygen and causing serious injuries including death, indicating that there was one complaint and one injury related to the use of this product, while no deaths were reported.
She recommended the isolation of the batch-carrying filters No. LT2103, and contacted the supplier for a replacement.
On the other hand, the Ministry warned against a number of operations of the medical device “BD Plastipak™️ 50mL syringe” due to the possibility of air leaking in the syringe when using the pump, which may lead to blockage of blood vessels when injecting.
Affected lots carry the numbers “BD Plastipak™️ 50mL Syringe with Luer-Lok™️ Tip with reference number MDS-22-4339 was limited to product code No. 300865”.
The ministry stated that the manufacturer will update the product label to ensure that the product will not be used if the product or packaging is damaged.