FDA Device recall Z-1877-2012
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG…
- FDA Device
- Class II
- terminated
- Published 2012-07-04
On 2012-07-04 the FDA classified a Class II recall of SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG… by Terumo Cardiovascular Systems, citing during production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of so….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1877-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-05-09 |
| Published | 2012-07-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Terumo Cardiovascular Systems |
| Distribution | US |
Product
SARNS ANTEGRADE CARDIOPLEGIA CANNULA: ROOT INFUSION CANNULA WITH 14-GAUGE WHITE NEEDLE,RECTANGULAR FLANGE AND SUTURE COLLAR, 6" (15CM) LONG Product Usage: The Sarns Cardioplegia Cannula and Cardioplegia/Vent Catheters are indicated for placement in the aortic root to deliver cardioplegia solution or blood to the heart, to vent the left heart, and to aspirate air from the aorta during cardiopulmonary bypass procedures.
Reason
During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface. The substance was likely deposited during the molding process, but the exact composition of the
Identifiers
| code_info | Catalog number: 203895 and lot numbers: 0551294, 0555085, 0557607, 0560171, 0563852, 0568020, 0572133, 0579089, 0586166…Catalog number: 203895 and lot numbers: 0551294, 0555085, 0557607, 0560171, 0563852, 0568020, 0572133, 0579089, 0586166, 0592735, 0598461, 0603720, 0611573, 0616893, 0619181, 0625003, 0633298, 0637811, 0640423, 0645344, 0649186, 0652248, 0655897, 0662813, and 621706C. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1877-2012%22
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