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.
- Company
- Cardiac Assist, Inc
- Recall Initiated
- October 14, 2021
- Recall Number
- Z-0311-2022
- Quantity
- 7 units
- Firm Location
- Pittsburgh, PA
Reason for Recall
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)
Distribution
US Distribution to states of: DC, MA, SC, and VA.
Lot / Code Info
Serial Numbers: 872170, 872171, 872172, 872173, 872182, 872183, 872184. UDI: 01)00814112020791(17)220 501(22)220511(21) 872170; (01)00814112020791(17)220 501(22)220511(21) 872171; (01)00814112020791(17)220 501(22)220511(21) 872172; (01)00814112020791(17)220 501(22)220511(21) 872173; (01)00814112020791(17)220 501(22)220511(21) 872182; (01)00814112020791(17)220 501(22)220511(21) 872183; 01)00814112020791(17)220 501(22)220511(21) 872184
Root Cause
Error in labeling
Action Taken
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 kit contained within your ordered kit as per Table provided in Attachment 1; - Please dispose of the outer packaging of your impacted product upon notification of this letter. - Please use your devices as labelled on the device level labeling. 2. Return the attached Response Form in Attachment 1 by email to LivaNova.FSCA@livanova.com to confirm appropriate corrective actions have been executed. Please return the Response Form even if each potentially affected device listed in Attachment 1 has already been used. For questions regarding this Medical Device Removal, please contact your TandemLife representative, or TandemLife Customer Quality at LivaNova.FSCA@livanova.com.