Reported Nov 12, 2014 · Terminated
Terumo Custom Cardioplegia Delivery Set- Catalog Number:165720 and Catalog Number: 6375 Product Usage: Cardioplegia…
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- Catalog Number165720
- and Catalog Number6375
- Product UsageCardioplegia 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 4I ratio. Includes a Conducer Heat Exchanger and a MP4 Temperature & Pressure Module. Additionally, the set is constructed with a female luer connector that is the subject of the correction/removal activity
- Lot codes and dates
- Catalog Number165720
- Lot Numbers
MDI5MD15BMD22ME19MP13. Manufacturing dates March 1520 I 0 through December 1320 I 0
- Catalog Number6375
- Lot Numbers
MD15ME19MPI3 Manufacturing dates March 152010 through December 1320 I 0
- Amount recalled
- Catalog: 16579 ; Catalog 6375: 3256 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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