Recall Z-0524-2021 ยท MLS Labor And Delivery Kit
ROi CPS LLC
Regard - Product Usage: Obstetric Gynecologic specialized manual instrument. Labor and delivery kits.
| Date | Dec 2, 2020 (initiated Oct 12, 2020) |
| Status | Terminated |
| Reason | Labeling error, incorrect expiration date. |
| Root cause | Labeling Change Control |
| Action | ROi CPS, LLC issued the recall in the form of customer notices sent through email on 10/12 2020. The customer recall notices required that the consignees review their inventory and segregate the affected kits, so a correction of affected kits can be coordinated . Kits reported to ROi CPS, LLC will be reworked to correct the labeling on each kit prior to releasing back to the consignees. ROi CPS, LLC requested that consignees forward the recall notice to any other users who may have received the affected kits. As of the date of this letter, no product has been returned to ROi CPS, LLC, we wil |
| Quantity | 220 kits |
| Distribution | US Nationwide distribution in the states of MO and OK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.