Smiths Medical needle sheath error leads to recall:
This article was originally published in Clinica
Executive Summary
Smiths Medical is conducting an urgent recall of batches of its Wallace dual lumen oocyte recovery needle sets used in IVF treatment, according to a Medicines and Healthcare products Regulatory Agency (MHRA) device alert, posted on January 27. The recall affects batches manufactured between February and June 2003, which were made with protective sheaths that are too short to cover the needle fully, with a risk that it can penetrate its outer packaging and make the device non-sterile. The MHRA had not received any reports of infections or lost IVF cycles, due to bacterial contamination resulting from the fault.