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Displaying 1 - 6 of 6 items.

" " Heater-Cooler Unit HCU 40
Maquet Cardiopulmonary GmbH determined two trends for complaints regarding the Heater Cooler Unit HCU 40: degraded internal drain hoses and leaking vacuum valves. This recall will inform users, and give instructions to replace affected parts during next…
RecallHealth product recall | 2023-03-17
" " Permanent Life Support and HLS Sets
Potentially compromised sterile barrier.  The conformity of the products was questioned by the German health authority due to packaging tests not adequately performed.  Single sterilized and transport conditioned according to ASTM d4169-22 was…
RecallHealth product recall | 2023-01-17
" " HLS Set Advanced Bioline Coating
The former packaging design of HLS set contains accessories packed in medical paper as opposed to the new introduced packaging design in Tyvek. Based on design verification tests it showed that medical paper is a weaker technical solution than Tyvek,…
RecallHealth product recall | 2022-07-25
" " Heater Unit Hu35
Statistical analysis indicates that with increasing operation time of the HU 35, the probability of leakage within its expected service life of 10 years increases due to material degradation of the tank fittings. Tank fittings and the screw cap of the…
RecallHealth product recall | 2022-05-30
" " Cardiohelp-I
Maquet Cardiopulmonary Gmbh has determined during the testing of a Cardiohelp-I, that the cylindrical pin in the upper part of the transport guard can come loose. the transport guard is an accessory of the Cardiohelp-I and secures the oxygenator to the…
RecallHealth product recall | 2022-02-28
" " Custom Tubing Packs
The tubing sets are designed and labeled for 2 years shelf-life from the manufacturing date. However, during a review of the technical documentation of tubing sets, it was found out that there is not sufficient evidence to demonstrate…
RecallHealth product recall | 2021-11-12
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