Recall Z-1285-2019— Cardinal Health 200, LLC

Name: FDA recall Z-1285-2019
Creator: U.S. Food and Drug Administration
Published: 2019-03-22

Class II · Terminated

Class II FDA medical device recall by Cardinal Health 200, LLC, initiated 2019-03-22, terminated 2021-08-06. It names one FDA 510(k) clearance: K002064. Product: ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills. Reason: Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap.

Recalling firm: Cardinal Health 200, LLC
Classification: Class II
Status: Terminated
Initiated: 2019-03-22
Terminated: 2021-08-06
Firm location: Mansfield, MA, 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

ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

Reason for recall

Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap

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