Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom, has posted a field safety notice concerning SUREFLUX 25UX LC GA [Lot numbers: 14I29F, 14L29F, 15B23F, 14I29F], a dialyzer manufactured by Nipro Europe V.
The manufacturer received complaints from the Japanese Market regarding a housing body crack of Dialyzer and a leakage of the saline or dialyzer solution. The position of the crack is near its header position.
The manufacturer found that the housings were misaligned because auxiliaries were bumped unintentionally into auxiliary removing device set before roughly-cutting process. Due to this, misaligned housings were contacted by holding jig at the next process and cracks were generated around the dialysate ports.
According to the manufacturer, there was no adverse event or health injury related to this problem having been reported so far.
The manufacturer is recalling the affected product and users are advised not to use the affected lots.
If you are in possession of the affected products, please contact your supplier for necessary actions.