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Recall Observatory FDA recall evidence

Device product

15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212

Z-2544-2021

August 10, 2021

Class II

Product summary

Firm
B. Braun Medical, Inc.
Event
Event 88531
Status
Terminated
Classification
Class II
Quantity
978,876 units
Official record key
device-enforcement:Z-2544-2021

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: 0061752459 0061752460 0061755100 0061755637 0061757837 0061757838 0061758588 0061759428 0061759475 0061761605 0061765911 0061766189 0061767026 0061767841 0061769047 0061769091 0061769931 0061770185 0061770486 0061771274 0061772190 0061775452 0061776078 0061776101 0061776773 0061776915 0061777160 0061777161 0061780362 Lot Codes: 0061780840 0061781779 00VL752554 DI: 04046964293832

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.