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
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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
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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 |
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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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