FDA recall Z-2545-2021

Product

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

Worldwide distribution - US Nationwide distribution and the country of Canada.

Key facts

Status

Terminated

Initiation date

2021-08-10

Report date

2021-10-06

Termination date

2024-09-16

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2545-2021