Recall Z-1285-2019 ยท LZA Polymer Patient Examination Glove
Cardinal Health 200, LLC
ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
| Date | Mar 22, 2019 |
| Status | Terminated |
| Reason | Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap |
| Root cause | Nonconforming Material/Component |
| Action | Cardinal Health issued recall letter dated March 22, 2019 stating reason for recall, health risk and Action Required: 1. INSPECT inventory.2. SEGREGATE and QUARANTINE all on-hand product. 3. RETURN the enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product youve quarantined or discarded. 4. NOTIFY customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notificati |
| Quantity | 3236 |
| Distribution | Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002064 | COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL Wrp Asia Pacific Sdn. Bhd., Nov 28, 2000 |