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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker CBCII with Quick Disconnect, 3/16 in. Double Trocar and Reinfusion Labels

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 Class 2 Recall
Stryker CBCII with Quick Disconnect, 3/16 in. Double Trocar and Reinfusion Labels
see related information
Date Posted January 29, 2010
Recall Status1 Terminated on October 25, 2010
Recall Number Z-0723-2010
Recall Event ID 54149
Premarket Notification
510(K) Number
K952224 
Product Classification Apparatus, Autotransfusion - Product Code cac
Product 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.
Code Information serial numbers 07362012 through 09187012.
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo, Michigan 49001
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Jennifer Mars
269-323-7700
Manufacturer Reason
for Recall
The product may not be sterile due to package not being intact.
FDA Determined
Cause 2
PRODUCTION CONTROLS: 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = cac and Original Applicant = STRYKER INSTRUMENTS
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