Recall Z-0936-2023 ยท KPE Container, I.V.
Stradis Healthcare
HCT 500mL BAGS, 2 Port, Sterile, Triple Packaged, 10 EVA BAGS/Pack, 7 Packs PER CASE. Distributed by Health Care Technology.
| Date | Jan 11, 2023 (initiated Dec 15, 2022) |
| Status | Open, Classified |
| Reason | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. |
| Root cause | Process control |
| Action | Stradis Healthcare notified consignees on about 12/15/2022 via email. The letter instructed consignees to examine inventory, immediately quarantine any affected product, contact Stradis Customer Care to arrange for return shipment of the recalled product, and to notify customers if the product was further distributed. Consignees were also asked to complete and return the Recall Acknowledgement Form. |
| Quantity | 644 units |
| Distribution | US Nationwide distribution in the states of FL, IL, IN, MA, MS, NV, OH, TN, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190328 | HCT Empty EVA Container Pack Health Care Technologies, Aug 15, 2019 |