Z-0740-2010

Stryker CBCII ConstaVac Blood Conservation Kit 3/16in. (4.8 mm) PVC, sterile, Stryker Instruments, Kalamazoo...

Name: Z-0740-2010 Stryker CBCII ConstaVac Blood Conservation Kit 3/16in. (4.8 mm) PVC, sterile, Stryker Instruments, Kalamazoo...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2009-11-12
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2009-11-12 / Terminated / root cause: packaging

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of Stryker CBCII ConstaVac Blood Conservation Kit 3/16in. (4.8 mm) PVC, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-426. Blood recovery system used... on 2009-11-12. The reason FDA records is "The product may not be sterile due to package not being intact". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0740-2010
Status: Terminated
Initiated: 2009-11-12
Posted: 2010-01-29
Terminated: 2010-10-25
Recalling firm: Stryker Corp.
Product: Stryker CBCII ConstaVac Blood Conservation Kit 3/16in. (4.8 mm) PVC, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-426. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
Product code: cac
Reason for recall: The product may not be sterile due to package not being intact.
Root cause tag: packaging
FDA 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 in commerce: 79, 617 all products.
Distribution: Worldwide Distribution.
Product codes and lots: serial number 07304012 through 09178012.

Product code cac

K952224Class IIStryker Constavac Blood Conservation System II (Cbcii)Stryker Instruments / cleared 1995-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)