FDA recall record

Cardinal Health 200 ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product recall — FDA Z-1285-2019

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

Class IIclassification
Z-1285-2019official record ID
May 15, 2019report date

Recall record at a glance

Official recordZ-1285-2019
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusTerminated
Recalling firmCardinal Health 200, LLC
Report dateMay 15, 2019
Recall initiation dateMar 22, 2019
Quantity3236
LocationMansfield, MA, United States

Official 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

Why the product was recalled

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

Distribution information

Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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