Recall Z-1724-2009 ยท CCN Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
Amvex Corporation
Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex Corporation, 25B East Pearce St, Richmond Hill, Ontario L4B 2M9, Canada; Model No. FI. The Integrated Flowmeter has two parts, the Outlet port and the Flowmeter port. The Outlet port is intended to be used as a standard wall Outlet, delivering a high flow of gas to secondary equipment. The Flowmeter port is
| Date | Aug 21, 2009 (initiated May 29, 2009) |
| Status | Terminated |
| Reason | The affected flowmeters may have a damaged o-ring which may cause the flowmeter to deliver higher amounts of gas and or not be able to shut off fully. |
| Root cause | Employee error |
| Action | An "Urgent: Medical Device Recall" letter dated May 29, 2009 was issued to the affected direct accounts on the same date, informing them that the Integrated Flowmeters shipped between April 12, 2007 and August 31, 2007 may experience damage to the o-ring which helps to control the flow of gas from the flowmeter portion of the outlet. Units with a damaged o-ring might deliver higher amounts of gas and/or not be able to shut off fully. The letter provided a list of the affected serial numbers, and asked the accounts to confirm that they have flowmeters from the recall time period. The accoun |
| Quantity | 1,424 units |
| Distribution | Worldwide Distribution -- US (including Puerto Rico), Canada, Iran, Peru, Taiwan and Thailand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.