Terumo Custom Cardiovascular and Perfusion Procedure recall
Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX…
Why was Terumo Custom Cardiovascular and Perfusion Procedure 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?
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.
- Product
- Terumo Custom Cardiovascular and Perfusion Procedure Kits Catalog Codes: Kits with a 5-digit code beginning with the digit 6: Catalog Number: 6XXXX…
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Quantity
- Catalog Number: 6XXXX: 4561 units; Catalog Number: 7xxxx : 19356 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)