B. Braun Medical, Inc.: PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239

Is my product affected?

PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 480239

• UPC 04046955137015

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

What happened

B. Braun Medical, Inc. is recalling 13,320 pump sets (Ref: 480239) designed for use with the Outlook Safety Infusion System and/or Horizon NXT Pump. These single-use pump sets were distributed worldwide, including nationwide in the US and Canada. The specific lot codes affected are 0061756804, 0061757753, and 0061777804.

The pump sets may leak within the cassette portion, which could delay medication administration, result in under-delivery or incomplete dosing, and potentially lead to bloodstream infections. The source document does not specify a remedy or what affected consumers should do.

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: 13,320 units Lot/code info: Lot Code: 0061756804 0061757753 0061777804 DI: 04046955137015

Source

Official record: FDA (Device enforcement) ↗

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

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