Reported Nov 12, 2014 · Terminated
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the…
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 Custom Cardiovascular and
- Perfusion Procedure Kits Catalog CodesKits with a 5-digit
- code beginning with the digit 6Catalog
- Number6XXXX
- Catalog CodesKits with a 5-digit
- code beginning with the digit 7Catalog
- Number7XXXX
- Product usageThe Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery. The Cardiovascular Procedure Kits are indicated for use only in the extracorporeal circuit for the cardiopulmonary bypass procedure(s) for which the user designed it
- Lot codes and dates
- Catalog Number6XXXX
- Lot Numbers
ML07MM18MM25MN08MN ISMN22. Manufacturing dates September 720 I 0 through November 2220 I 0
- Catalog Number7XXXX
- Lot Numbers
ML07ML20MM18MM25MNO1MN08MN15MN29MP06MP13. Manufacturing dates September 72010 through December 132010
- Amount recalled
- Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 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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