Cardiac Assist SHIP Kit: Incorrect Expiration Date on Package Labels
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.
Lower-risk 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)
Contact the company
What happened, in plain English
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. Read more at govinfonow.com/recall/61688-cardiac-assist-ship-kit-incorrect-expiration-date-on-package-labels.
Source Summary by GovInfoNow · govinfonow.com/recall/61688-cardiac-assist-ship-kit-incorrect-expiration-date-on-package-labels · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0311-2022
Cite this page
“Cardiac Assist SHIP Kit: Incorrect Expiration Date on Package Labels.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61688-cardiac-assist-ship-kit-incorrect-expiration-date-on-package-labels. Based on FDA recall #Z-0311-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0311-2022%22&limit=1).
Why it’s dangerous
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.
Who’s affected
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.
How to tell if you have this one
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.
- Brand
Cardiac Assist- Product
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components- Category
Medical device
What to do — step by step
Verify Kit Expiration Date
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.
Where it went and when
Where it was distributed
Distributed in 3 states and D.C..
FDA distribution: “US Distribution to states of: DC, MA, SC, and VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: District of Columbia, Massachusetts, South Carolina, Virginia.
Recall timeline
FDA published this recall 55 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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.
- Official source: FDA Recall #Z-0311-2022 (October 14, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0311-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.