Z-0311-2022Class III

SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following...

Name: Z-0311-2022 SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following...
Creator: Cardiac Assist, Inc
Published: 2021-10-14
License: https://open.fda.gov/license/

Cardiac Assist, Inc / initiated 2021-10-14 / Open, Classified / root cause: labeling and UDI

FDA source

Cardiac Assist, Inc began a recall of SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula... on 2021-10-14. FDA classified it as Class III and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0311-2022
Classification: Class III
Status: Open, Classified
Initiated: 2021-10-14
Posted: 2021-11-29
Recalling firm: Cardiac Assist, Inc
Product: 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.
Product code: DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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)
Root cause tag: labeling and UDI
FDA 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 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 [email protected] 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 [email protected].
Quantity in commerce: 7 units
Distribution: US Distribution to states of: DC, MA, SC, and VA.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0311-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0311-2022	Class III	Ongoing	Voluntary: Firm initiated	2021-12-08	2021-11-29

Product code DWF

K160257Class IIPROTEK Duo 31 Fr. Veno-Venous Cannula SetCardiacassist, Inc. / cleared 2016-03-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)