FDAFDA · Food and drugs·Recall number Z-0159-2015
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX ; Catalog Codes: Kits with a 5-digit code beginning with the digit 7: Catalog Number: 7XXXX Product usage: The 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.
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
- Catalog Number: 6XXXX Lot Numbers: ML07, MM18, MM25, MN08, MN IS, MN22. Manufacturing dates September 7, 20 I 0 through November 22, 20 I 0. Catalog Number: 7XXXX Lot Numbers: ML07,ML20, MM18, MM25, MNO1, MN08, MN15, MN29,MP06, MP13. Manufacturing dates September 7, 2010 through December 13,2010.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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