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U.S. Department of Health and Human Services

Class 1 Device Recall MOST

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  Class 1 Device Recall MOST see related information
Date Initiated by Firm September 08, 2007
Date Posted August 28, 2008
Recall Status1 Terminated 3 on November 01, 2012
Recall Number Z-2201-2008
Recall Event ID 49030
510(K)Number K040738  K061414  
Product Classification mobile oxygen storage tank - Product Code CAW
Product Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002
Code Information Serial numbers: 6947-001 to 6947-546, 6968-001 to 6968-211, 6982-001 to 6982-134, C4340-24, C4340-25, 7224-001 to 7224-011, and 10001 to 10194.
Recalling Firm/
Manufacturer		 Pacific Consolidated Industries LLC
12201 Magnolia Ave
Riverside CA 92503-4820
For Additional Information Contact
951-479-0860
Manufacturer Reason
for Recall		 The recall was initiated after the firm received two customer complaints of ruptured bourdon tubes that had resulted in bellowed out face gauges. With one unit the operator was able to shut off the oxygen flow, however one rupture resulted in a fire. No injuries were reported.
FDA Determined
Cause 2		 Vendor change control
Action PCI sent a Recall Notification letter to the Spanish Air Force September 8, 2007. The Recall Notification letter was mailed to the US Defense Supply Center on July 24, 2008 after a recall agreement was signed on July 8, 2008 between Pacific Consolidated Industries and the Defense Supply Center. The recall notification to Spanish Air Force informed the consignee of the problem and asked the consignee to remove the affected units from service until a Technical Service Representative could be sent to Spain to inspect the affected units and perform the corrective action. The recall notification to Defense Supply Center instructed the consignee to keep the affected units in quarantine (units placed in quarantine by US Air Force August 3, 2007) until they have been refurbished under recall agreement that was signed on July 8, 2008.
Quantity in Commerce 1032 units
Distribution Worldwide to US Air Force and also to Spain
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 = CAW and Original Applicant = PACIFIC CONSOLIDATED INDUSTRIES LLP
510(K)s with Product Code = CAW and Original Applicant = PACIFIC CONSOLIDATED INDUSTRIES, LLC
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