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.
This recall is currently active, issued October 14, 2021. It was issued by Cardiac Assist, Inc.
- Company
- Cardiac Assist, Inc
- Recall Initiated
- October 14, 2021
- Recall Number
- Z-0311-2022
- Quantity
- 7 units
- Firm Location
- Pittsburgh, PA
- Official Source
- View on FDA website ↗
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.