Device 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
Z-1285-2019
Product summary
- Event
- Event 82535
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3236
- Official record key
device-enforcement:Z-1285-2019
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: 235508X, 303205X, 305701X, 307708X, 308126X, 309206X, 319602X, 320504X, 323204X, 410837X, 413643X, 414326X, 416430X, 422701X, 430016X, 430442X, 431828X, 434226X, 434528X, 506449X, 619595X, 622266X, 624614X, 625363X, 629806X, 703411X, 705165X, 706224X, 708004X, 710351X, 712123X, 719186X, 720507X, 723650X, 729905X, 734723X, 803018X, 812171X, 817809X, 823430X, 825704X, 826721X
Distribution pattern: Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan
Derived failure modes
-
Unknown
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap