Urgent Public Warning over 1ml Subcutaneous  Syringes

The Technical Regulations Division within the Malta Competition & Consumer Affairs Authority (MCCAA), in collaboration with the Ministry of Health, the Elderly & Community Care, wishes to inform the public of an immediate and urgent recall concerning 1ml (100 unit) disposable insulin syringes, batch number 20110120, manufactured by Anhui Tiankang Medical Products Co Ltd.

These products are marked with “CE-0123” marking, “100 IU/ml 29G”. Although these syringes are largely used for insulin administration by diabetics, they can also be used by other population groups such as patients taking anticoagulants (e.g. heparin). This recall affects all syringes of the above-mentioned batch, irrespective of the solution they administer.

Under normal circumstances, such 1ml syringes would be graduated with numbers from “20” to “100”, with “100” denoting a total maximum volume of 1ml. However, in some syringes the graduations were discovered to only read “40” units as a maximum volume, despite the fact that the maximum volume contained in the syringe would still actually be 1ml. This could potentially mislead patients who could believe that they have actually administered themselves a volume of only 0.4ml, when in reality they have administered the full 1ml. There is therefore a high health risk should such patients administer additional solution than actually needed.

The photo accompanying this Press Release displays the identified problem.

Whilst the number of erroneously graduated syringes found is expected to be relatively small, a preventive recall of all the syringes from the affected batch has been implemented. Pharmacies of Your Choice (POYCs) and Health Care Clinics are already adequately supplied with 0.5ml correctly-graduated syringes as a replacement. In this regard, all patients in possession of the affected 1ml syringes are strongly advised to immediately call at their nearest POYC or Health Care Clinic to replace their syringes.

As of today, Saturday 17th September till 8pm and tomorrow Sunday 18th September from 7am till 7pm replacement stocks of 0.5ml can also be collected from the Outpatient Pharmacy at Mater Dei Hospital as a contingency measure in the eventuality that any particular Pharmacy or Health Care Centre falls out of stock from this item.

As from next Monday 19th September, additional stocks of 0.5ml syringes will also be made available through the POYC and within the Health Care Centres.

It should be finally noted that no further safety issues have been identified at this stage with other types or sizes of syringes used on the local market, and therefore such other syringes can continue to be used safely, in accordance with the normal procedures and instructions for use.

For any further queries or clarifications on the above matter, kindly contact your nearest POYC or Health Care Clinic.