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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker CBCII ConstaVac Blood conservation system

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 Class 2 Device Recall Stryker CBCII ConstaVac Blood conservation systemsee related information
Date Initiated by FirmNovember 12, 2009
Date PostedJanuary 29, 2010
Recall Status1 Terminated 3 on October 25, 2010
Recall NumberZ-0719-2010
Recall Event ID 54149
510(K)NumberK952224 
Product Classification Apparatus, autotransfusion - Product Code cac
ProductStryker CBCII ConstaVac Blood conservation system, sterile, Stryker Instruments, Kalamazoo, MI, REF 225-28E. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood.
Code Information serial numbers 07303012 through 09173032
Recalling Firm/
Manufacturer		 Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
For Additional Information ContactJennifer Mars
269-323-7700
Manufacturer Reason
for Recall		The product may not be sterile due to package not being intact.
FDA Determined
Cause 2		Packaging process control
ActionStryker 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 Commerce79,617 for all products
DistributionWorldwide Distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = cac
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