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Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002

FDA device recall Z-2201-2008 · posted 2008-08-28 · Terminated

Recall details

Recalling firm
Pacific Consolidated Industries LLC
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.
Action taken
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.
Root cause
Vendor change control
Status
Terminated
Product code
CAW
Quantity affected
1032 units
Distribution
Worldwide to US Air Force and also to Spain
Date initiated
2007-09-08
Date posted
2008-08-28
Date terminated
2012-11-01
Location
Riverside, CA

Monitor recalls programmatically

Recalls and clearances share one API, with change alerts when new recalls post.

Related 510(k) clearances

RecordFirmDate
EXPEDITIONARY DELPLOYABLE OXYGEN CONCENTRATION SYSTEM (EDOCS), MODELS 120B AND 30;MOBILE OXYGEN STORAGE TANK (MOST), MOD (K061414)Pacific Consolidated Industries, LLC2007-01-22
MOBILE OXYGEN STORAGE TANK (MOST) (K040738)Pacific Consolidated Industries Llp2004-04-30