Recall Z-1690-2023— Cardinal Health 200, LLC

Name: FDA recall Z-1690-2023
Creator: U.S. Food and Drug Administration
Published: 2023-04-06

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2023-04-06. FDA's recall record names no specific 510(k) clearance for this event. Product: Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery. Reason: Inadvertently released for distibution without sterility assurance..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Ongoing
Initiated: 2023-04-06
Firm location: Waukegan, IL, United States

Product description

Presource Kit, SMA21LPUHJ GYN Laparoscopy Pack. Convenience kit used for Laparoscopic surgery

Reason for recall

Inadvertently released for distibution without sterility assurance.

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