Recall Z-1275-2021 ยท IWJ System, Applicator, Radionuclide, Manual
Sirtex Medical Limited
SIROS D-Vial Prep Set, Product Code SIR-10200 - Product Usage: intended for single use.
| Date | Mar 18, 2021 (initiated Feb 22, 2021) |
| Status | Terminated |
| Reason | There is a potential presence of particulate matter in the D-Vial. |
| Root cause | Other |
| Action | Urgent Voluntary Medical Device Recall notification letters dated 2/22/21 were distributed to customers. Actions to be taken by the Customer/User: Sirtex is directing customers not to use the product from the recalled lots. Recalled product should be returned to Sirtex for credit. Please forward the notice in the event affected products were further distributed. Please fill out and return the attached Customer Acknowledgement and Receipt Form to QA@sirtex.com. Please complete this form whether or not you have affected product on hand. A mailing label will be provided via email for the return |
| Quantity | 3310 |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.