B. Braun Medical, Inc.: Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids

Is my product affected?

Outlook Pump Sets w/3 CARESITE Needle-Free Injection Sites: single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Material ID: 352413

• UPC 04046964182211

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

What happened

B. Braun Medical is recalling approximately 585,576 Outlook Pump Sets with 3 CARESITE Needle-Free Injection Sites designed for use with the Outlook Safety Infusion System and/or Horizon NXT Pump. These single-use pump sets are used to deliver parenteral fluids to patients. The recall affects units distributed nationwide in the US and in Canada. The recall involves specific lot codes identified in the recall notice.

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 recall record does not specify a remedy or course of 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: 585,576 units Lot/code info: Lot Code: 0061755638 0061757839 0061759426 0061763839 0061763893 0061763894 0061766190 0061767014 0061767027 0061768466 0061769094 0061772192 0061772193 0061775455 0061776025 0061776298 0061776299 0061776300 0061776301 0061777154 00VL752555 00VL754131 DI: 04046964182211

Source

Official record: FDA (Device enforcement) ↗

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

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