Stryker CBCII ConstaVac Blood Collection Only System with 1/8in. (3.2mm) PVC Drains and Double 1/8in. (3.2mm) Trocar, st
FDA device recall Z-0735-2010 · posted 2010-01-29 · Terminated
Recall details
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Reason for recall
- The product may not be sterile due to package not being intact.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- cac
- Quantity affected
- 79,617 all products.
- Distribution
- Worldwide Distribution.
- Date initiated
- 2009-11-12
- Date posted
- 2010-01-29
- Date terminated
- 2010-10-25
- Location
- Kalamazoo, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER CONSTAVAC BLOOD CONSERVATION SYSTEM II (CBCII) (K952224) | Stryker Instruments | 1995-11-17 |