Medical device manufacturer, Steripack S.A, has issued a medical device safety alert concerning its Steriflush Prefilled 0.9% Sodium Chloride Syringes and Procedure Packs Containing Steriflush Prefilled 0.9% Sodium Chloride Syringes. The affected devices are identified as follows:

• Product Reference Number: 14363SAL, 14360S, 14361S, 14366S, 14362S, 14363S, 14364S, TP-50-10, 14363SNSAL, 14365SNSF, 14360SNS, 14361SNS, 14362SNS, 14363SNS, 14364SNS, 14365SNS, 14366SNS, 100470, 10606901, 10606902, 10606911, 10606912, 10606913, 10606914, 10609006, 10601030, 10609007 and 10605810

According to the manufacturer, brown particles have been found inside the prefilled syringe containing 0.9% NaCl. After investigation, the manufacturer concluded that there was an interaction between the sodium chloride 0.9% and the trace metals present in the rubber stopper, which could potentially generate extremely small brown particles. And the health risk associated with this issue is small as no incident or patient safety has ever been involved.

The manufacturer is instructing affected users to return the devices.

If you are in possession of the products, please contact your supplier for necessary action.

Posted on 11 February 2021