Recall Z-1561-2010 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Precision Medical, Inc.
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.
| Date | May 9, 2010 (initiated Mar 5, 2010) |
| Status | Terminated |
| Reason | The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be turned "off" |
| Root cause | Labeling mix-ups |
| 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K843223 | FLOW CONTROLLER Precision Medical, Inc., Sep 27, 1984 |