Z-2547-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 6, 2021
- Initiation Date
- August 10, 2021
- Termination Date
- September 16, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,960 units
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the country of Canada.
Code Information
Lot Code: 0061758630 0061763934 DI: 04046964182259