PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter and is used to direct the outlet flow from any standard flowmeter to any one of the three outlets it provides.
FDA Recall Z-1561-2010 · Posted 2010-05-09
Recalling FirmPrecision Medical, Inc.
Recall StatusTerminated
Product CodeBTM
Date Initiated2010-03-05
Date Terminated2010-12-13
Product Quantity19,518
Reason for Recall
The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be turned "off"
Firm Action
The recalling firm issued Customer Alert Product Recall letters on 3/5/10 to inform users of the problem and how to identify affected product.
Root Cause
Labeling mix-ups
Distribution Pattern
The products were shipped to distributor and medical facilities nationwide. The products were also shipped to Taiwan, Germany, Hong Kong, Canada
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.