medical Class II Updated 2024-01-10

Natus Medical Incorporated recalls External Drainage System Collection Bag, REF: NT821732C, ST

Recalled Product

External Drainage System Collection Bag, REF: NT821732C, STERILEEO, Rx only


Hazard / Issue

Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455
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