—#87643

Product

Stryker CBCII Double Trocar Kit with 1/8 in. (3.2mm) Drain, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-614. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.

FDA product code: cac
510(k) numbers: K952224
Affected lot / code info: serial numbers 07311012 through 09183022.

Why it was recalled

The product may not be sterile due to package not being intact.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Kalamazoo, Michigan 49001

Distribution

Distribution pattern: Worldwide Distribution.

Timeline

Recall initiated: 2009-11-12
Posted by FDA: 2010-01-29
Terminated: 2010-10-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #87643. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.