PlainRecalls
FDA Devices Moderate Class II Terminated

60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215

Reported: October 6, 2021 Initiated: August 10, 2021 #Z-2547-2021

Product Description

60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215

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.

Details

Recalling Firm
B. Braun Medical, Inc.
Units Affected
1,960 units
Distribution
Worldwide distribution - US Nationwide distribution and the country of Canada.
Location
Allentown, PA

Frequently Asked Questions

What product was recalled?
60 drops/ml, Priming volume: 25 ml, Length: 120 in.in-single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of parenteral fluids Ref: 354215. Recalled by B. Braun Medical, Inc.. Units affected: 1,960 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2547-2021.