Reported Nov 12, 2014 · Terminated
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for…
Terumo Cardiovascular Systems Corp.
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: Terumo Cardiovascular Systems Corp · 28 Howe St · Ashland, MA · 01721-1305
Is this the product you have?
- Terumo
- Cardioplegia Delivery Set- Item Number16130
- Product UsageThe Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery
- Lot codes and dates
- Lot Numbers
MN08MNI5MM11MM18MM25. Manufacturing dates October 1I2010 through Novemberl520 I 0
- Lot Numbers
- Amount recalled
- 777 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
- Nationwide
Why it was recalled
Defect in the luer connector can compromise the seal on the female side of the connector. and the compromised seal can introduce air in the table line
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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