Stryker CBCII with Quick Disconnect and 3/16 in. Double Trocar, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28-S5. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
FDA Recall Z-0724-2010 · Posted 2010-01-29
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Recalling FirmStryker Instruments Div. of Stryker Corporation
Recall StatusTerminated
Product Codecac
Date Initiated2009-11-12
Date Terminated2010-10-25
Product Quantity79,617 all products
Reason for Recall
The product may not be sterile due to package not being intact.
Firm 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.
Root Cause
Packaging process control
Distribution Pattern
Worldwide Distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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