FDA recall Z-0747-2024

Product

48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi), List Number MX694R

Reason for recall

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Key facts

Status

Ongoing

Initiation date

2023-11-10

Report date

2024-01-24

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dublin, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0747-2024