Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a
FDA device recall Z-0157-2015 · posted 2014-10-31 · Terminated
Recall details
- Recalling firm
- Terumo Cardiovascular Systems Corp
- Reason for recall
- 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
- Action taken
- Terumo Cardiovascualr notified accounts by letter dated 3/1/2011 advising users users that the luer connector to the table line in certain lots of myocardial protection sets may leak. Users should not continue to use affected myocardial protection sets in a manner that exposes the connector to negative pressure without taking correction or replacement activities as described. Firm provided mitigating instructions: Clamp the table line distal to the luer connector when ending an infusion of cardioplegia thus isolating the leak from negative pressure. Contact Terumo CVS Customer Service to report the defect and arrange return of the unit: 800-521-2818.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KRI
- Quantity affected
- 165 units
- Distribution
- Worldwide Distribution: US (nationwide) and the countries of Canada, Brazil, Hong Kong, Korea, and Thailand.
- Date initiated
- 2011-03-01
- Date posted
- 2014-10-31
- Date terminated
- 2014-11-06
- Location
- Ashland, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SARNS INTEGRATED CARDIOPLEGIA DELIV. SYS (K810079) | 3M Health Care, Sarns | 1981-01-30 |