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U.S. Department of Health and Human Services

Class 2 Device Recall Drager Medical Air Compressor

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  Class 2 Device Recall Drager Medical Air Compressor see related information
Date Initiated by Firm January 26, 2007
Date Posted April 05, 2007
Recall Status1 Terminated 3 on June 15, 2007
Recall Number Z-0674-2007
Recall Event ID 37188
510(K)Number K982789  
Product Classification Medical Air Compressor - Product Code BTI
Product Medical Air Compressor
Model #8413419
Code Information Model number 8413419. Catalog number 8413419. Serial Numbers ARXC-001; ARXC-0002; ARXC-0009; ARXC-0011; ARXC-0012; ARXC-0013; ARXC-0014; ARXC-0015; ARXC-0016; ARXC-0017; ARXC-0019; ARXC-0020; ARXD-0034; ARXD-0035; ARXD-0036; ARXD-0037; ARXD-0038; ARXD-0039; ARXD-0040; ARXE-0081; ARXE-0082; ARXE-0083; ARXE-0084; ARXE-0085; ARXE-0086; ARXE-0087; ARXE-0088; ARXE-0089; ARXE-0090; ARXE-0091; ARXE-0092; ARXE-0093; ARXE-0094; ARXE-0095; ARXE-0096; ARXE-0097; ARXE-0098; ARXE-0099; ARXE0100; ARXE-0101; ARXE-0102; ARXE-0103; ARXE-0104; ARXE-0106; ARXE-0107; ARXE-0108; ARXE-0109; ARXE-0110; ARXE-0111; ARXE-0112; ARXE-0113; ARXE-0114; ARXE-0115; ARXE-0116; ARXE-0117; ARXE-0118; ARXE-0119; ARXE-0120; ARXE-0121; ARXE-0122; ARXE-0123; ARXE-0124; ARXE-0125; ARXE-0126; ARXE-0127; ARXE-0128; and ARXE-0129.
Recalling Firm/
Manufacturer
Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Mike Kelhart
215-660-2349
Manufacturer Reason
for Recall
Compressors not providing sufficient supply pressure to connected medical ventilator
FDA Determined
Cause 2
Other
Action The recalling firm issued a Medical Device Recall Letter dated 1/22/07 to their customers via Certified Mail. An authorized service representative will inspect each potentially affected device. If a device is found to have an affected dryer assembly, it will be repaired free of charge.
Quantity in Commerce 67 units
Distribution Nationwide.
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.
510(K) Database 510(K)s with Product Code = BTI and Original Applicant = DRAGER, INC.
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