| Date Initiated by Firm | December 05, 2013 |
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| Date Posted | January 28, 2014 |
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| Recall Status1 |
Terminated 3 on February 05, 2015 |
| Recall Number | Z-0848-2014 |
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| Recall Event ID |
67100 |
| 510(K)Number | K023354 |
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| Product Classification |
Compressor, air, portable - Product Code BTI
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| Product | Compressor Mini
To provide a supply of dry, filtered compressed air for a medical respiratory ventilator or anaesthesia machine that meet the specifications of the compressor mini. compressor mini is intended to be operated by healthcare providers, physicians, nurses, and technicians. Compressor mini is to be used only for bedside application within the hospital environment. Compressor mini is neither intended nor suitable for use during in-hospital patient transportation or during ambulance or air transportation. Compressor mini is not suitable for use with MRI. |
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| Code Information |
Part number 6481779 |
Recalling Firm/
Manufacturer |
Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Drive
Wayne NJ 07470
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Manufacturer Reason
for Recall | Maquet Compressor Mini may deliver compressed air at a temperature higher than specified. |
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FDA Determined
Cause 2 | Material/Component Contamination |
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| Action | Maquet sent a product recall urgent-medical device field correction letter/customer fax response via Fed Ex on December 5, 2013, to their customers.
Customers are advised of the issues with the device and provided instructions. The correction will include an update with replacement of the affected connector and if needed replacement of the thermoelectric cooler if it damaged. These operations will be performed by an authorized Maquet representative. Any questions can be directed to customer service at 1-888-627-8383 option 2 followed by option 3 Monday through Friday between the hours of 8 am and 6 pm EST.
Customers should completed and return the enclosed confirmation form or scan a copy to field actions@maquet.com or fax (973) 807-9290. |
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| Quantity in Commerce | 237 units |
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| Distribution | Worldwide Distribution US, Canada and Japan. |
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| 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 = BTI
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