UK MHRA has issued alerts on certain batches of the products listed in the title, the reason being that in both products Smiths Medical had become aware of an increase in the number of reports of disconnections of the Luer lock connector at the patient end of the tubing. This can lead to a risk of fluid/ blood loss or delay in therapy.
Smith Medical issued Field Safety Notices pertaining to these products in November 2011, and MHRA is now following up with its own alert, stating that it “cannot be confident that these recalls have been effective and that users have received and acted on the information provided in the manufacturer’s Field Safety Notices.”
MHRA’s device alert can be found here and includes details of who is affected and what to do at this point. Note that the original notice includes details of affected batches and instructs users not to use the devices.
Source: MHRA
published: March 2, 2012 in: Alerts/Adverse Events