Recall Z-0085-2024— Cardinal Health 200, LLC

Name: FDA recall Z-0085-2024
Creator: U.S. Food and Drug Administration
Published: 2023-08-16

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2023-08-16. FDA's recall record names no specific 510(k) clearance for this event. Product: Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.. Reason: Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits)..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-08-16
Firm location: Waukegan, IL, United States

Product description

Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Data sourced from openFDA. This site is unofficial and independent of the FDA.