FDA Medical Device Recalls (openFDA)
Stryker Instruments Div. of Stryker Corporation: Stryker CBCII ConstaVac Blood Conservation System with Quick Disconnect and 1/4in. (6.4mm) PVC Drain, sterile, Stryker Instruments, Kalamazoo, MI REF 225-28-916. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
- Recall number
- Z-0733-2010
- Recalling firm
- Stryker Instruments Div. of Stryker Corporation
- Product
- Stryker CBCII ConstaVac Blood Conservation System with Quick Disconnect and 1/4in. (6.4mm) PVC Drain, sterile, Stryker Instruments, Kalamazoo, MI REF 225-28-916. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
- Status
- Terminated
- Initiated
- 2009-11-12
- Posted
- 2010-01-29
- Terminated
- 2010-10-25
- 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.
- Lot, serial or model codes
- serial numbers 07310012 through 09159012
- 510(k) numbers
- ["K952224"]
- PMA numbers
- not on file
- Product code
- cac
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28