MSD recalls hospitals to withdraw colostomy bags, catheters from hospitals immediately

Colombo, June 22 (Daily Mirror) - The Medical Supplies Division (MSD) has ordered the immediate withdrawal of several batches of two medical devices supplied to government hospitals — a colostomy appliance and an angiographic catheter — following reports of defects and performance issues that could affect patient safety and treatment outcomes.

According to an MSD circular, several batches of the "Colostomy Appliance Set Complete" manufactured by China's BAO Health Medical Instruments Co., Ltd. have been recalled following recommendations by the National Medicines Regulatory Authority (NMRA) and the Medical Device Evaluation Committee (MDEC).

The circular stated that the defective batches were found to have poor adhesion and could cause skin irritation, reducing the effective duration of colostomy bag usage among patients.

Health authorities have instructed all hospitals, provincial and regional health services directors and medical institutions to immediately stop using and withdraw the affected batches from circulation.

The batches ordered to be withdrawn are DD202508-1301, DD202311-19 and DD202405-01.

The MSD said the withdrawal was based on a letter received from the NMRA and that all relevant institutions have been directed to ensure the products are removed from use without delay.

Health officials have also been instructed to circulate the notice among all healthcare institutions under their purview and comply with existing procedures governing the recall of medical devices.

Meanwhile, a batch of angiographic catheters used in coronary procedures has also been ordered withdrawn from government hospitals following reports of performance issues that could pose safety concerns during angiography procedures.

The MSD has issued a separate circular directing all health institutions to immediately stop using and withdraw the affected batch of the Angiographic Catheter, TIG, size 5F, 110 cm, supplied under government procurement.

According to the circular, the decision was taken following recommendations by the NMRA and the 103rd Medical Device Evaluation Committee (MDEC).The affected product, manufactured by PendraCare International B.V. of the Netherlands and marketed under the brand name Angiodyn, is from batch number 2307-0076.

The MSD said clinicians had reported several issues while using the catheter, including poor torque control, difficulty in manoeuvring, challenges in reliably engaging the right coronary artery, and a tendency for the catheter to engage too deeply during procedures, raising potential patient safety concerns.

Acting on instructions from the NMRA, the MSD has directed all provincial and regional health authorities, teaching hospitals and other government medical institutions to immediately withdraw the affected batch from use and ensure the circular is circulated among relevant healthcare facilities.The recalled batch has an expiry date of June 30, 2026.