Pacific Consolidated Industries Mobile Oxygen Storage Tank…

Date posted by the FDA

Aug. 28, 2008

Status

Terminated

Filed by

Pacific Consolidated Industries LLC

Product

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

Reason

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.

Distribution pattern

Worldwide to US Air Force and also to Spain

Quantity

1032 units

Codes and lots

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.

Recall started

Sept. 8, 2007

Device type

Generator, Oxygen, Portable

Root cause (FDA)

Vendor change control

What the company told customers

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.

Recall number

Z-2201-2008

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2201-2008. The agency record governs; check it and the company before acting.