Device Alert: X-Ray Detectable Swabs May Not Be X-Ray Detectable

In short

UK competent authority, the MHRA has issued a Medical Device Alert(MDA) pertaining to an X-Ray detectable swab which appears to suffer from stripping out of the radio-opaque strip, thereby presenting the threat that it could be left inside patients and not detectable by subsequent X-Rays.

Background

This situation has emanated from UK company Frontier Multigate, which manufactures gauze swabs containing a radio-opaque strip for the aforementioned purpose. It appears that excessive irradiation dose during manufacturing may have caused shredding of the strip, potentially causing it to disintegrate and no longer produce a viable signal from the swab.

The MDA relates to one specific lot of one particular product as follows:

X-ray detectable gauze swabs, Multi-X 10 cm x 7.5 cm 32 ply. Cat no:82410/S2005. Lot: 12401406

Manufactured by Frontier Multigate

The MDA follows a field safety notice issued by the company in October and calls for the identification, quarantine and return to manufacturer of all affected pieces.

The full MDA can be found here.