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U.S. Department of Health and Human Services

Class 2 Device Recall Cerner Bridge Medical Transfusion Administration and Specimen Collections

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  Class 2 Device Recall Cerner Bridge Medical Transfusion Administration and Specimen Collections see related information
Date Initiated by Firm January 19, 2009
Date Posted May 01, 2009
Recall Status1 Terminated 3 on March 22, 2012
Recall Number Z-1236-2009
Recall Event ID 51319
Product Classification Calculator/data processing module, for clinical use - Product Code JQP
Product Cerner Bridge Medical Transfusion Administration and Specimen Collections, Versions 3.4.0, 3.4.1 and 3.4.2.
Code Information Software Versions 3.4.0, 3.4.1 and 3.4.2.
Recalling Firm/
Manufacturer		 Cerner Corp
2800 Rockcreek Pkwy
Kansas City MO 64117-2521
For Additional Information Contact Shelley S. Looby, BS MT(ASCP)BB
816-201-1368
Manufacturer Reason
for Recall		 Specimen labels printing incorrect patient demographics.
FDA Determined
Cause 2		 Software design
Action Cerner Corporation issued a "Priority Review Flash" dated January 15, 2009 via e-mail to consignees using the software. The letter described the violative nature of the software and explained the proper navigation controls needed to prevent further issues. Further questions should be addressed to Bridge Client Support at 1-800-786-0239.
Quantity in Commerce 4
Distribution Nationwide distribution to states of OH, NC, MO and MI.
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.
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