Recall Z-2480-2018 ยท LRP Tray, Surgical
Cardinal Health 200, LLC
Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is ut
| Date | Feb 20, 2018 |
| Status | Terminated |
| Reason | A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit. |
| Root cause | Packaging |
| Action | Cardinal Health notified customers via Fed Ex overnight, on about 02/21/2018. The URGENT PRODUCT RECALL letter instructed customers to: 1) Inspect your inventory for the affected product code and lot number; 2)Segregate and quarantine all product on hand; 3) Return 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; 4) Notify any customers to whom you may have distributed product affected by this recall; 5)Contact Customer Service at 800-964-5227 to arrange re |
| Quantity | 8,928 kits total |
| Distribution | US Nationwide Distribution in the states of California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.