FDAFDA · Food and drugs·Recall number Z-0161-2015
Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the subject of this correction/removal activity
Published November 12, 2014 · Recall initiated: March 1, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Terumo Cardiovascular Systems Corp
- Distributor
- Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
- Lot
- Lot Numbers: MN08 Manufacturing Date November 8, 20 I 0.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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