Recall Z-0737-2010 ยท CAC Apparatus, Autotransfusion
Stryker Instruments Div. of Stryker Corporation
Stryker CBCII ConstaVac Blood Conservation Kit 1/8in. (3.2mm) PVC w/o Fat Retention Valve, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-414S2. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
| Date | Jan 29, 2010 (initiated Nov 12, 2009) |
| Status | Terminated |
| Reason | The product may not be sterile due to package not being intact. |
| Root cause | Packaging process control |
| Action | Stryker issued a "Medical Device Recall Notification" via email to foreign consignees dated November 12, 2009. Stryker further issued recall letters via overnight mail to domestic consginees beginning November 20, 2009. These notifications informed consignees of the affected devices instructing them to destroy all affected product and return a completed Business Reply Form to the firm. For further information, contact Stryker Instruments at 1-800-800-4236 extension 3808. |
| Quantity | 79,617 all products |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952224 | STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) Stryker Instruments, Nov 17, 1995 |