Recall Z-2685-2024 ยท KPE Container, I.V.
ROi CPS LLC
Regard Kit containing the Microtek decanter
| Date | Aug 16, 2024 (initiated Jun 17, 2024) |
| Status | Open, Classified |
| Reason | Decanters may have pin holes and tears in sterile packaging that cannot be identified visually. |
| Root cause | Pending |
| Action | The distributor was notified of the recall via letter emailed on 06/17/2024. The distributor was instructed to review their inventory to determine if the item listed in the letter is in the inventory; complete and return a response form, notify any customers to whom the product was distributed, end users should immediately quarantine any affected kits at their facility and discontinue use, and report any adverse health consequences experienced with the product to FDA. |
| Quantity | 78 Kits |
| Distribution | US Nationwide distribution in the state of MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.