FDA-Device2021-10-06Class II

Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214

B. Braun Medical, Inc.
Hazard

Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

Sold states
Worldwide distribution - US Nationwide distribution and the country of Canada.
Affected count
44,866 units
Manufactured in
901 Marcon Blvd, N/A, Allentown, PA, United States
Products
Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with 2 CARESITE¿ Y-Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354214

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2546-2021

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