Reported Nov 12, 2014 · Terminated
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product…
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 Cardioplegia Delivery Set - Heat Exchanger
- Cardiopulmonary Bypass Item Numbers
585216010
- Product UsageThis is a Cardioplegia Delivery System that is designed to delivery blood/solution to the patient undergoing cardiopulmonary bypass surgery. The set is designed
- to deliver blood/solutions at a 41 ratio. In includes a Conducer Heat Exchanger and a Bubble Trap module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity
- Lot codes and dates
- Item Number58520-Lot
- Numbers
MF24MM11MN01. Manufacturing dates May 2420 I 0 through November I2010
- Item Number1610-Lot
- Numbers
MM11MN08MNI5MN29 MP07. Manufacturing dates October 1120 I 0 through December 720 I 0
- Amount recalled
- 596 units; 876 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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