FDA recall Z-2376-2024

Product

OUTLOOK IV SET 15DROP W/2 CARESITE-Used with an electrically-powered infusion pump for intravenous (IV) administration of medication. Model/Catalog Number: 354212

Reason for recall

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product malfunction with loss of medication/blood.

Distribution

Worldwide distribution - US Nationwide and the country of Canada.

Key facts

Status

Ongoing

Initiation date

2024-06-17

Report date

2024-07-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Allentown, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2376-2024