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B. Braun Medical, Inc. Recall 88531

Description: Y-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005

B. Braun Medical, Inc. Recall 88531 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2553-2021
Event ID88531
Event DescriptionY-Type Blood, Outlook Pump Set, Caresite-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 477005
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution and the country of Canada.
Quantity1,752 units
Recall ReasonLeakage 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.
Device Classification20211006
Device Code InfoLot Code: 0061772234 DI: 04046955202799
Center Classification Date20210924
Recall Initiation Date20210810
Recalling FirmB. Braun Medical, Inc.
Initial Notification Letter
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