B. Braun Medical, Inc.: 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: 354

Is my product affected?

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

• UPC 04046964182273

Check against the official notice below — it lists the full affected range.

What happened

B. Braun Medical, Inc. is recalling 55,584 units of pump sets (Ref: 354) designed for use with Outlook Safety Infusion System and/or Horizon NXT Pump systems. These single-use pump sets, which deliver 10 drops/ml with a priming volume of 46ml and length of 130 inches, were distributed nationwide in the US and in Canada. The recall involves specific lot codes: 0061760493, 0061763906, 0061764288, 0061765128, and 0061771281.

The pump sets may leak within the cassette portion, which could delay medication administration, result in under-delivery or incomplete dosing of medications, and potentially cause bloodstream infections. The record does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Worldwide distribution - US Nationwide distribution and the country of Canada. Quantity: 55,584 units Lot/code info: Lot Code: 0061760493 0061763906 0061764288 0061765128 0061771281 DI: 04046964182273

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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