FDA recall Z-0944-2023

Stradis Healthcare · Class II · device

Product

Stradis Healthcare TCTR Convenience Kit. Manufactured by Stradis Healthcare.

Reason for recall

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Distribution

US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA.

Key facts

Status
Ongoing
Initiation date
2022-12-15
Report date
2023-01-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0944-2023