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Teleflex recalls manifolds used in breathing systems after manufacturer's notice

Teleflex Inc. is recalling certain lots of a breathing circuit manifold manufactured by Taiwan-based private company GaleMed Corp. due to defects that lead to pressure loss in the breathing system.

Babi.Plus water pressure relief manifolds are used within ventilation systems for patients weighing less than 10 kilograms. GaleMed sent Teleflex a notice regarding defects in the device due to which the breathing system will not hold pressure.

The third-party manufacturer received two reports about the device malfunction, Teleflex noted in the Oct. 7 press release.

The U.S. Food and Drug Administration has classified the recall as a class I recall — the most serious type of recall. The regulatory agency noted that there is a reasonable probability that the use of defective products will cause serious adverse health consequences or death.

The Wayne, Pa.-based healthcare equipment manufacturer started the recall on June 14 and has asked consumers to discontinue the use of affected products and return them to Teleflex. The recalled products were distributed between October 2018 and May 2019.

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