🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: October 14, 2021 Cardiac Assist Implants & Prosthetics

What Should You Do?

  1. Check if you have this product:
    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
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Cardiac Assist, Inc
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)
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

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 Codes/Lot Numbers:

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

Distribution:

Distributed in: US, DC, MA, SC, VA

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-0311-2022

Related Recalls

LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained within the Kit numbers: 5830-2916 LS TANDEMLIFE KIT DL29 5840-2417 LS TANDEMLIFE KIT - V24, A17

Cardiac Assist

Class I - Dangerous

Epoxy used during manufacturing of the LifeSPARC Pump may have uncured epoxy. if undetectable curing may result in added risk of early pump failure,

Jun 30, 2023 Infusion Pumps Nationwide View Details →

SHIP KIT, LIFESPARC, CONTROLLER AND ACCESSORIES - 5900-0000; SHIP KIT, LIFESPARC, CONTROLLER ONLY - 5900-0001. Component of LifeSPARC System, used to pump the blood through an extracorporeal circuit.

Cardiac Assist

Class I - Dangerous

A software update (v1.1.5) has been developed to address the issue of Critical Failure which can occur on the LifeSPARC Controller. The Critical Failure was first addressed in the firm's recall initiated July 21, 2022. During the Critical Failure, the software freezes or crashes and the screen does not display data.

Dec 5, 2022 Implants & Prosthetics Nationwide View Details →