FDA recall Z-0993-2023

Product

Cardinal Health Jackson-Pratt Channel Drain, 28 Fr, REF JP-2290

Reason for recall

Cardinal Health recently received multiple complaints regarding various performance issues with Cardinal Health Jackson-Pratt Channel Drains including lack of radiopacity in wound drains, dull trocars impacting product performance, lack of flexibility of wound drains, and broken wound tips.

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.

Key facts

Status

Ongoing

Initiation date

2022-12-14

Report date

2023-01-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Waukegan, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0993-2023