Date Initiated by Firm | March 21, 2008 |
Date Posted | September 16, 2008 |
Recall Status1 |
Terminated 3 on October 29, 2008 |
Recall Number | Z-1692-2008 |
Recall Event ID |
47523 |
510(K)Number | K970460 |
Product Classification |
Ventilator - Product Code CBK
|
Product | Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802, Puritan-Bennett Corporation, A subsidiary of Mallinckrodt Inc., Carlsbad, CA |
Code Information |
4-070523-SP Battery Assembly 4-840120DIUU-US 4-070520-SP BPS |
Recalling Firm/ Manufacturer |
Covidien Limited 6135 Gunbarrel Ave Boulder CO 80301-3214
|
For Additional Information Contact | 303-305-2382 |
Manufacturer Reason for Recall | Wiring in battery back-up power supply may short and cause thermal damage to ventilator. |
FDA Determined Cause 2 | Process control |
Action | All customers were notified by Federal Express letter and were contacted by phone through field service engineers. They were told to examine their inventory for any installed or spare part battery assemblies and to remove and quarantine these parts. Any ventilators with installed affected battery assemblies were to be taken out of service. |
Quantity in Commerce | 6 Ventilators and 151 factory replacement units |
Distribution | Nationwide, including one VA facility in IL and two military facilities in NC and NY. No foreign 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 = CBK
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