Reported May 22, 2024 · Ongoing
Medtronic Cardioplegia Adapters
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
Medtronic Cardioplegia Adapters
7 of 7 products
| Model / number | Product as published |
|---|---|
25009 | DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter |
25010 | DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter |
14003 | DLP¿ 30.5 cm (12 in) Multiple Perfusion Set |
14000 | DLP¿ 38.1 cm (15 in) Multiple Perfusion Set |
11001G | DLP¿ 50.8 cm (20 in) Extension Line Adapter |
13002 | DLP¿ Perfusion/Venting Adapter |
10710 | DLP¿ Y Adapter Coronary Perfusion |
- Lot codes and dates
10 of 10 products
Products covered by this recall Model / number Product as published 20613994918608Model Number 25009, , Lot Numbers: 2023040212, 202305C110 20613994918585Model Number 25010, , Lot Numbers: 2023041227, 202305C111 00613994619662Model Number 14003, , Lot Numbers: 2023040464 20613994619666Model Number 14003, , Lot Numbers: 2023040463, 2023040464, 202305C102 00613994619716Model Number 14000, , Lot Numbers: 2023041205, 2023041206 20613994619710Model Number 14000, , Lot Numbers: 2023041205, 2023041206, 202305C098, 202305C099 00613994918550Model Number 11001G, , Lot Numbers: 2023031005 20613994918554Model Number 11001G, , Lot Numbers: 2023030371, 2023030659, 2023031004, 2023031005, 2023031530, 2023040160, 2023040431, 2023040432, 2023040804, 2023040805, 2023041171, 202306C131, 202306C136, 202308C218 20613994756057Model Number 13002, , Lot Numbers: 2023040459, 202305C097 20613994685937Model Number 10710, , Lot Numbers: 20613994685937 - Amount recalled
- 6290 units
This recall covers 13 products
The agency filed one notice per product. You are reading one of them; the other 12 are below.
Why it was recalled
Potential for unsealed sterile packing.
This product could cause temporary or reversible health problems — stop using it.
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