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

Hazard

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

Details from the source

Reason for recall: Sterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. Distribution: US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV. Quantity: 2,686 units Lot/code info: UDI: 00382830050562/ Lot #: 1FX0004951660 1FX0004951658 1FX0004951659 1FX0005040450 1FX0005040451 1FX0005040452 1FX0005040453 1FX0005040454 1FX0005040457 1FX0005040456 1FX0005079696 1FX0005126475 1FX0005126474 1FX0005040455

UPC codes

00382830050562

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.