Recall Z-0200-06 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Terumo Cardiovascular Systems Corp
Terumo Sarns brand Flexible arterial cannula, 7.5 mm (22 Fr) OD with 3/8 inch connector, suture ring, 9.5 inches (24 cm) long, catalog number 13020, sterile, single use only.
| Date | Nov 26, 2005 (initiated Sep 12, 2005) |
| Status | Terminated |
| Reason | There may be a solvent bond failure at the tubing/connector site of the cannula, resulting in the disconnection of the cannula parts. |
| Root cause | Other |
| Action | Consignees were sent a recall letter dated September 12, 2005, via FedEx, email or fax between 9/12/05 and 9/14/05. |
| Quantity | 2520 |
| Distribution | Nationwide, Australia, Canada, China, Germany, Japan, Thailand and United Arab Emirate. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K771499 | FLEXIBLE ARTERIAL CANNULAE 3M Health Care, Sarns, Aug 16, 1977 |