B. Braun Medical, Inc.: 15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material

Is my product affected?

15 drops/ml, Priming Volume: 27ml, Length: 129 in. Single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluid Material ID: 354212

• UPC 04046964293832

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

What happened

B. Braun Medical, Inc. is recalling approximately 978,876 single-use pump sets designed for use with the Outlook Safety Infusion System and Horizon NXT Pump. The recalled units 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 products were distributed worldwide, including throughout the United States and Canada, and are identified by specific lot codes beginning with 006 and 00VL, or the device identifier 04046964293832.

The recall notice 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: 978,876 units Lot/code info: Lot Code: 0061752459 0061752460 0061755100 0061755637 0061757837 0061757838 0061758588 0061759428 0061759475 0061761605 0061765911 0061766189 0061767026 0061767841 0061769047 0061769091 0061769931 0061770185 0061770486 0061771274 0061772190 0061775452 0061776078 0061776101 0061776773 0061776915 0061777160 0061777161 0061780362 Lot Codes: 0061780840 0061781779 00VL752554 DI: 04046964293832

Source

Official record: FDA (Device enforcement) ↗

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

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