Fort Lauderdale, Florida – February 28, 2020 – Several alerts have recently been issued by not only the USA’s FDA governing body on medical devices but also the Chinese governing body on medical devices. The alerts were issued by both countries after several brands of medical devices used globally and made in China, were found to have fecal contamination that could prove deadly.
Chinese products for the preparation of Platelet Rich Plasma (PRP), principally commercialized under the Healeon PRP and Manson PRP brand names, with all medical devices originating from the same manufacturer called Beijing Hanbaihan Medical Devices Co. Ltd. (HBH) have been identified as non-conforming and hazardous.
The Chinese CFDA has declared that the HBH manufacturing facility in China has been shut down. The US-FDA website indicates that HBH’s manufacturing facility has never been inspected. Manson PRP defective tubes have been infected by fecal origin bacteria Escherichia Coli used in hospitals in Poland.
Defective tubes commercialized by Healeon Medical (Healeon PRP) and Bellus Medical in the USA have been withdrawn from the market because of similar infections; there was a recall of products reported to the US-FDA.
The regulatory entity in Europe called TÜV Süd (notified body) declared that the company Beijing Manson Technology Co. Ltd has illegally affixed TÜV Süd’s CE0123 and mark on their Manson PRP products as evidenced from TÜV Süd’s website*. The Manson PRP products therefore do not hold CE certification and cannot be commercialized in Europe. Following investigation, TÜV Süd has even cancelled HBH’s CE certificate which is therefore not valid anymore.
Chinese (HBH) kits are also sold under other various non-conforming/dubious brand names in the USA, namely Juventix Medical PRP Kit, Suneva Medical HD PRP, Integrity PRP kit, Medshift PRP, Prizmah PRP and CellTherapy PRP kit.
As more news is released on this situation, it will be reported as soon as possible.
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