Cardiac Assist recalls specific cardiac bypass kits due to incorrect expiration date labels on packaging. Affected kits may have safety risks if used without proper expiration verification.
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)
Cardiac Assist is recalling specific cardiac bypass kits (SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31) because the side label shows an incorrect expiration date (2021/05/01) instead of the correct date (2022/05/01). This could lead to improper use if the kit is used after the incorrect expiration date.
The kits have a label showing an incorrect expiration date (2021/05/01) on the side label instead of the correct date (2022/05/01). This could cause the kit to be used after its expiration date, potentially leading to improper function during critical cardiac procedures.
Healthcare professionals using the specific kits with serial numbers 872170-872184 are most at risk. Patients undergoing cardiac surgery may be affected if the incorrect expiration date leads to improper kit usage.
Check for the kit serial numbers 872170 through 872184. The kits include specific components like the 31 Fr ProtekDuo Veno-Venous Cannula Set and LifeSPARC Pump. The kit number is 5820-3118.
Check the side label for the expiration date (should be 2022/05/01) on the outer package of the kit. If it shows 2021/05/01, contact Cardiac Assist for further instructions.
The side label shows an incorrect expiration date (2021/05/01) instead of the correct date (2022/05/01). This could lead to improper use if the kit is used after the incorrect expiration date.
The correct expiration date is 2022/05/01. The side label shows an incorrect expiration date of 2021/05/01.
Check for the kit serial numbers 872170 through 872184. The kits include specific components like the 31 Fr ProtekDuo Veno-Venous Cannula Set and LifeSPARC Pump.
We’ve drafted a message you can send Cardiac Assist to request your refund or repair — edit it as you like.
Subject: Recall Z-0311-2022 — Cardiac Assist Cardiac Assist Hello, I own a Cardiac Assist that is covered by recall Z-0311-2022 from Cardiac Assist. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
