Product Safety Recalls

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B. Braun Medical, Inc. Recall 88531

Description: 10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216

B. Braun Medical, Inc. Recall 88531 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2548-2021
Event ID88531
Event Description10 drops/ml, Priming volume: 46ml, Length: 130 in.-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354216
Product TypeDevices
DistributionWorldwide distribution - US Nationwide distribution and the country of Canada.
Quantity55,584 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: 0061760493 0061763906 0061764288 0061765128 0061771281 DI: 04046964182273
Center Classification Date20210924
Recall Initiation Date20210810
Recalling FirmB. Braun Medical, Inc.
Initial Notification Letter
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