Urgent recall of insulin syringes

An immediate and urgent recall concerning 1ml (100 unit) disposable insulin syringes, batch number 20110120, manufactured by Anhui Tiankang Medical Products Co Ltd has been issued.

The recall was issued by the technical regulations division within the Malta Competition & Consumer Affairs Authority and the Health Ministry.

In a statement they said 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, such as heparin.

This recall affects all syringes of the said 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 number of erroneously graduated syringes is expected to be relatively small.

Pharmacies of Your Choice (POYCs) and Health Care Clinics are already adequately supplied with 0.5ml correctly-graduated syringes as a replacement.

All patients in possession of the affected 1ml syringes are strongly advised to immediately call and obtain replacements from health care clinics. Patients registered with the POYC scheme may exchange their syringes at their POYC pharmacy.

Replacements of 0.5ml can also be collected from the Outpatient Pharmacy at Mater Dei As until 8 p.m. today and from 7 a.m. to 7 p.m. tomorrow.

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