Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
FDA Recall #Z-0991-2023 — Class II — December 14, 2022
Product Description
Cardinal Health Jackson-Pratt Channel Drain, 15 Fr, REF JP-2233
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.
Recalling Firm
Cardinal Health 200, LLC — Waukegan, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1920 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Saudi Arabia, Singapore, Hong Kong.
Code Information
UDI/DI 50885380182653(cs), 20885380182652(ea), Lot Numbers: N210278, N210368, N210423, N210460, N210468, N210543, N220050, N220099, N220139, N220163
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.