Recall Z-1351-04 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Sarns brand Retrograde Cardioplegia Cannulae, manual-inflate, 13 Fr, guidewire stylet, ribbed balloon; catalog number 5580.
| Date | Aug 17, 2004 (initiated Jul 7, 2004) |
| Status | Terminated |
| Reason | The product is labeled as sterile, but sterility is compromised because some of the packages were not sealed. |
| Root cause | Other |
| Action | The firm issued a recall letter for some lots on 7/7/04, instructing customers to examine stocks on hand for open packages and to return product without a package seal. The recall was extended to all lots via a second recall letter dated July 29, 2004. |
| Distribution | United States, Brazil, Canada, Chile, Colombia, El Salvador, Germany, Hong Kong, Malaysia, Mexico, Nicaragua, South Africa, Taiwan, Thailand, United Arab Emirate, Uruguay and Wales. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925442 | SARNS RETROGRADE CANNULA 3M Health Care, Sarns, May 21, 1993 |