Device product
ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
Z-1286-2019
Product summary
- Event
- Event 82535
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5415
- Official record key
device-enforcement:Z-1286-2019
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: 235609, 303919X, 308148X, 311604X, 312606X, 318318X, 324933X, 328469X, 332206X, 333619X, 400228X, 404307X, 407209X, 410401X, 411560X, 413642X, 421208X, 425562X, 431002X, 433930X, 500815X, 502094X, 508526X, 509804X, 518003X, 523602X, 526504X, 531034X, 535770X, 604188X, 608358X, 611322X, 613451X, 621800X, 625601X, 628817X, 631332X, 634400X, 704641X, 707612X, 711572X, 714407X, 717902X, 723502X, 727719X, 731410X, 735208X, 802308X, 812169X, 815024X, 814519X, 817810X, 827112X, 827610X, 830967X, 833057X
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