FDAFDA · Food and drugs·Recall number Z-0158-2015
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmonary bypass surgery.
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, MNI5, MM11, MM18, MM25. Manufacturing dates October 1I, 2010 through Novemberl5, 20 I 0.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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