Recall Z-0531-2022 ยท MDM Instrument, Manual, Surgical, General Use
FlexDex Inc.
8mm FlexDex Needle Driver, Product Code FD-335 ND
| Date | Dec 22, 2021 |
| Status | Terminated |
| Reason | The firm is reinforcing the IFU instructions: "Do not use if the package is damaged." If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm sent a letter to customers reiterating the IFU's statement "Do not use if package is damaged." This is important to ensure the sterility of the product. If upon inspection of the packaging, any damage is observed, including pinholes or tears in the pouch, the product should not be used. Please forward this letter on to all those who need to be aware within your organization and to any other organizations (e.g. customers) on which this has an impact. |
| Quantity | 273 |
| Distribution | n/a |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.