Recall Z-1561-2010
Precision Medical, Inc. · initiated March 5, 2010
Product
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.
Codes / lots: Lot numbers 1209 and 0110
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"
FDA-determined cause: Labeling mix-ups
Action taken
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.
Details
- Recall number
- Z-1561-2010
- Initiated
- March 5, 2010
- Posted by FDA
- May 9, 2010
- Terminated
- December 13, 2010
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Quantity
- 19,518
- Distribution
- The products were shipped to distributor and medical facilities nationwide. The products were also shipped to Taiwan, Germany, Hong Kong, Canada
- Recalling firm
- Precision Medical, Inc., Northampton, PA