Recall Z-0558-2021 ยท NGY Cannula, Trocar, Ophthalmic
Mani, Inc. - Kiyohara Facility
MANI Infusion Cannula 23G S - Product Usage: for use in injecting perfusate or aspirating out intraocular materials during ophthalmic surgery Ref: MTC 23S
| Date | Oct 27, 2020 |
| Status | Terminated |
| Reason | Dimensions of the Luer connector parts out of specification, may cause leakage of fluid and unintended disconnection during use |
| Root cause | Unknown/Undetermined by firm |
| Action | MANI Inc. issued Voluntary Removal letter issued on 10/27/20 via email to the US Distributor stating reason for removal, health risk and action to take: request distributors to return the devices. If there are MANI TROCAR KIT and MANI INFUSION CANNULA in your stock and/or your customer's stock: Please write the returning Q'ty. in the list ,"Returned" If MANI TROCAR KIT and MANI INFUSION CANNULA are already used up : Please write the used Q'ty. in the list , "Used. Please send this sheet and relevant items if you have to our address below. Any costs/fees related to this return shipment should |
| Quantity | 60 units (US) |
| 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.