Recall Z-0311-2022 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Cardiac Assist, Inc
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.
| Date | Oct 14, 2021 |
| Status | Open, Classified |
| Reason | Top label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label showed expiration date of 2021/05/01 (incorrect expiration date) |
| Root cause | Error in labeling |
| Action | LiNova issued an "URGENT MEDICAL DEVICE REMOVAL" letter (FA-CP-PIT-2021-003) dated October 13th, 2021 via e-mail on 14 October 2021. Letter states reason for recall, health risk and action to take: TandemLife recommends using the device as labelled and dispose the outer packaging. TandemLife kindly requests your execution of the following actions: 1. Using attached Response Form in Attachment 1 of this letter, please: - If you have already discarded of outer packaging prior to the receipt of this letter, please proceed to step 2 - Check your inventory for the presence of potentially affected k |
| Quantity | 7 units |
| Distribution | US Distribution to states of: DC, MA, SC, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K160257 | PROTEK Duo 31 Fr. Veno-Venous Cannula Set Cardiacassist, Inc., Mar 4, 2016 |