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.
