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Terminated

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

FDA Recall Z-2201-2008 · Posted 2008-08-28

Recall StatusTerminated
Product CodeCAW
Date Initiated2007-09-08
Date Terminated2012-11-01
Product Quantity1032 units

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.

Firm 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.

Root Cause

Vendor change control

Distribution Pattern

Worldwide to US Air Force and also to Spain

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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