Medical Device Alerts issued in September 2019

Alerts were issued about T34 ambulatory syringe pumps, Gripper needles, and 1-day Acuvue Moist for astigmatism contact lenses.

In this monthly update, we highlight selected Medical Device Alerts and notices that have been issued recently by MHRA. Please note, this is not an exhaustive list of medical device alerts. For all Medical Device Alerts from MHRA, see Alerts and recalls for drugs and medical devices.

All models of T34 ambulatory syringe pumps – updated cleaning advice and maintenance requirements due to the risk of fluid ingress (MDA/2019/030). Issued 18 September 2019. Manufactured by CME (a BD company). Function may be affected by fluid getting into the pump and building up over time because of specific cleaning and disinfection practices. Updated guidance is given in the alert for cleaning and maintenance.

Deltec Gripper non-coring needles and PORT-A-CATH trays containing Gripper needles – recall due to risk of needle occlusion. Issued 12 September 2019. Manufactured by Smiths Medical. Due to a manufacturing process failure, needles may be occluded, potentially causing a delay to treatment. Affected devices should be identified and quarantined and returned to the manufacturer.

Johnson & Johnson Vision 1-day Acuvue Moist for Astigmatism contact lenses. Issued 26 September 2019. Certain lots of contact lenses have been recalled following a limited number of reports of foreign matter on the lens or in the lens blister solution. The Field Safety Notice asks opticians or optometrists to review their inventory and stop use of affected products. Patients who may have received any of the affected contact lenses should be contacted and if they have affected batches, instructed to discontinue use immediately and return the product for replacement.

Article citation: Drug Safety Update volume 13, issue 3: October 2019: 6.

Published 18 October 2019