Date Initiated by Firm | November 12, 2009 |
Date Posted | January 29, 2010 |
Recall Status1 |
Terminated 3 on October 25, 2010 |
Recall Number | Z-0742-2010 |
Recall Event ID |
54149 |
510(K)Number | K952224 |
Product Classification |
Apparatus, autotransfusion - Product Code cac
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Product | Stryker CBCII Collection only pkg/6 with 1/8 in Trocar, sterile, Stryker Instruments, Kalamazoo, MI, REF 0225-028-S21.
Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. |
Code Information |
serial numbers 08016012 through 09115012. |
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 all products. |
Distribution | Worldwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = cac
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