Terumo Custom Cardioplegia Delivery Set - Heat recall
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia…
Why was Terumo Custom Cardioplegia Delivery Set - Heat 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
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item Number: 58520-Lot Numbers: MF24, MM11, MN01. Manufacturing dates May 24, 20 I 0 through November I, 2010 Item Number: 1610-Lot Numbers: MM11, MN08, MNI5, MN29 MP07. Manufacturing dates October 11, 20 I 0 through December 7, 20 I 0
- Product
- Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia…
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Quantity
- 596 units; 876 units
- Distribution
- Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
- Recall date
- November 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)