Recall Z-1938-2021— Cardinal Health Inc.

Name: FDA recall Z-1938-2021
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. It names one FDA 510(k) clearance: K062195. Product: ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443. 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

510(k) clearances named in this recall

1 on FDA's record

K062195 — MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEMLifescan, Inc.·cleared 2006-08-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ONETOUCH ULTRA TEST STRIPS 25 COUNT Item Number: 3510443

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.