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Recall Observatory FDA recall evidence

Device product

ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

Z-1284-2019

March 22, 2019

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 82535
Status
Terminated
Classification
Class II
Quantity
21082
Official record key
device-enforcement:Z-1284-2019

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 Numbers: 708265X, 709766X, 712108X, 713853X, 719505X, 723645X, 726111X, 727029X, 730304X, 735321X, 803307X, 803990X, 808097X, 809318X, 812914X, 815537X, 821910X, 825016X, 826407X, 833752X

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