Recall Z-0902-2022— Cardinal Health 200, LLC

Name: FDA recall Z-0902-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-15

Class II · Completed

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2022-03-15. It names one FDA 510(k) clearance: K110272. Product: Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves. Reason: Product was distributed without being sterilized..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Completed
Initiated: 2022-03-15
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K110272 — STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGCardinal Health, Inc.·cleared 2011-06-08

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

Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves

Reason for recall

Product was distributed without being sterilized.

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