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Recall Observatory FDA recall evidence

Device product

Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413

Z-2545-2021

August 10, 2021

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 88531
Status
Terminated
Classification
Class II
Quantity
585,576 units
Official record key
device-enforcement:Z-2545-2021

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: 0061755638 0061757839 0061759426 0061763839 0061763893 0061763894 0061766190 0061767014 0061767027 0061768466 0061769094 0061772192 0061772193 0061775455 0061776025 0061776298 0061776299 0061776300 0061776301 0061777154 00VL752555 00VL754131 DI: 04046964182211

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.