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Recall Observatory FDA recall evidence

Device product

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

Z-2546-2021

August 10, 2021

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 88531
Status
Terminated
Classification
Class II
Quantity
44,866 units
Official record key
device-enforcement:Z-2546-2021

Official wording

Reason: 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.

Code information: Lot Code: 0061752471 0061756801 0061757861 0061766196 0061777798 DI: 04046964182235

Distribution pattern: Worldwide distribution - US Nationwide distribution and the country of Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.