Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2201-2008

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

Pacific Consolidated Industries LLC / initiated 2007-09-08 / Terminated / root cause: supplier

Pacific Consolidated Industries LLC began a recall of Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002 on . The reason FDA records is "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as supplier.

Recall record

Recall number
Z-2201-2008
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Pacific Consolidated Industries LLC
Product
Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B, Part Number: 793080-002
Product code
CAW Generator, Oxygen, Portable
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.
Root cause tag
supplier
FDA root cause
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
Product 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.