FDA recall Z-1735-2024

Cardinal Health 200, LLC · Class II · device

Product

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D

Reason for recall

Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.

Distribution

Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.

Key facts

Status
Ongoing
Initiation date
2024-03-27
Report date
2024-05-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1735-2024