Z-2545-2021 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
- 585,576 units
Product Description
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
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: 0061755638 0061757839 0061759426 0061763839 0061763893 0061763894 0061766190 0061767014 0061767027 0061768466 0061769094 0061772192 0061772193 0061775455 0061776025 0061776298 0061776299 0061776300 0061776301 0061777154 00VL752555 00VL754131 DI: 04046964182211