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Recall Observatory FDA recall evidence

Device product

ChemoPlus Chemo Spill Kit Product Code:CT4004 Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

Z-1283-2019

March 22, 2019

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 82535
Status
Terminated
Classification
Class II
Quantity
11588
Official record key
device-enforcement:Z-1283-2019

Official wording

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

Code information: Lot Nubers: 720708X, 723514X, 728548X, 733515X, 800821X, 802618X, 807122X, 808204X, 811703X, 816569X, 821916X, 826363X, 826065X, 828859X, 835143X

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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