Z-1285-2019 Class II Terminated
FDA device recall Z-1285-2019 was initiated by Cardinal Health 200, LLC on March 22, 2019 and is designated Class II. Reason for recall: Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap The recall status is terminated (terminated August 6, 2021). Affected quantity: 3236.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2019
- Initiation Date
- March 22, 2019
- Termination Date
- August 6, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3236
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
Reason for Recall
Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap
Distribution Pattern
Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan
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