Recall Z-1939-2021— Cardinal Health Inc.

Name: FDA recall Z-1939-2021
Creator: U.S. Food and Drug Administration
Published: 2021-03-16

Class II · Ongoing

Class II FDA medical device recall by Cardinal Health Inc., initiated 2021-03-16. FDA's recall record names no specific 510(k) clearance for this event. Product: ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610. Reason: Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results..

Recalling firm: Cardinal Health Inc.
Classification: Class II
Status: Ongoing
Initiated: 2021-03-16
Firm location: Dublin, OH, United States

Product description

ONETOUCH DELICA LANCETS 30G 100 COUNT Item Number: 5541610

Reason for recall

Due to shipping delays the devices were exposed to temperature excursions of 31.9¿F, intermittently over a 2 hour and 15 minute period of time which may cause inaccurate results.

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