Stryker CBCII with Quick Disconnect, 3/16 in. Double Trocar and Reinfusion Labels, sterile Stryker Instruments, Kalamazoo, MI, REF 225-28-85S4. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
This recall has been terminated (originally issued January 29, 2010).
- Recall Initiated
- November 12, 2009
- Posted
- January 29, 2010
- Terminated
- October 25, 2010
- Recall Number
- Z-0723-2010
- Quantity
- 79,617 all products
- Firm Location
- Kalamazoo, MI
- Official Source
- View on FDA website ↗
Reason for Recall
The product may not be sterile due to package not being intact.
Distribution
Worldwide Distribution.
Lot / Code Info
serial numbers 07362012 through 09187012.
Root Cause
Packaging process control
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.
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