Recall Z-1080-2021— Cardinal Health 200, LLC

Name: FDA recall Z-1080-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-07

Class II · Terminated

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2021-01-07, terminated 2024-02-14. It names one FDA 510(k) clearance: K972615. Product: CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004. Reason: Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns..

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Terminated
Initiated: 2021-01-07
Terminated: 2024-02-14
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K972615 — CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)Wembley Rubber Products (M) Sdn Bhd·cleared 1999-01-26

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

CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004

Reason for recall

Gowns included in the kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material or debris on the gowns.

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