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dinsdag 12 maart 2019

IGJ waarschuwingen: Protek Medical Products, FSCA 2019_02, Sterile PullUp Form-Fitted Probe Cover Kit

Protek Medical Products, FSCA 2019_02, Sterile PullUp Form-Fitted Probe Cover Kit
The cover broke during use in a laparoscopic procedure with trocar. However, this probe cover is not intended to be used in laparoscopic procedure with trocar.
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Etac AS, Etac Supply Gjovik, FSCA Molift 2-point sling bar
Etac supply Gjovik has received reports claiming that parts of the composite hook of the 2-Point Sling Bar has unintentionally broken off.
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William Cook 2019FA0001 - Inferior Vena Cava (IVC) Filter
This Field Safety Notice is provided to reinforce the recommendations provided in the Cook IVC Filter IFUs
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Luminex CAN-0233 - ARIES Cassettes
Luminex recently identified a manufacturing defect in the back seal (see Figure 1, Item 11) of our ARIES® cassettes.
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Vyaire Medical FSCA_2019-001 - enFlow® fluid warming system
This Field Safety Corrective Action has been initiated due to concerns raised regarding the potential risk of aluminium exposure to patients.
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