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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker CBCII Double Trocar Kit with 1/8 in. (3.2mm) Drain,

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  Class 2 Device Recall Stryker CBCII Double Trocar Kit with 1/8 in. (3.2mm) Drain, see related information
Date Initiated by Firm November 12, 2009
Date Posting Updated January 29, 2010
Recall Status1 Terminated 3 on October 25, 2010
Recall Number Z-0728-2010
Recall Event ID 54149
510(K)Number k952224  
Product Classification Apparatus, autotransfusion - Product Code cac
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.
Code Information serial numbers 07311012 through 09183022.
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E. Milham Ave.
Kalamazoo MI 49001
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
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
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = cac and Original Applicant = STRYKER INSTRUMENTS
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