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FDA (Device enforcement)Recalled 2021-08-10closedclass ii

B. Braun Medical, Inc.: OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004

Is my product affected?

OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 474004

  • UPC 04046964857263

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

What happened

B. Braun Medical, Inc. is recalling 12,216 units of the OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE (single-use) designed for use with the Outlook Safety Infusion System and Horizon NXT Pump. The recalled product may leak within the cassette portion of the pump sets, which could delay medication administration, result in under-delivery or incomplete dosing, and potentially cause bloodstream infections. The affected lot codes are 0061755664, 0061757771, 0061757873, 0061763933, 0061768487, and 0061786789.

The recalled pump sets were distributed worldwide, including throughout the United States and Canada. The source document does not specify what actions affected consumers should take in response to this recall.

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: 12,216 units Lot/code info: Lot Code: 0061755664 0061757771 0061757873 0061763933 0061768487 0061786789 DI: 04046964857263

Source

Official record: FDA (Device enforcement) ↗

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

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