Recall Z-1079-2021— Cardinal Health 200, LLC

Name: FDA recall Z-1079-2021
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: K002064. Product: CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K. 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

K002064 — COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABELWrp Asia Pacific Sdn. Bhd.·cleared 2000-11-28

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

CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K

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.