PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a flowmeter a
FDA device recall Z-1561-2010 · posted 2010-05-09 · Terminated
Recall details
- Recalling firm
- Precision Medical, Inc.
- 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"
- 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.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 19,518
- Distribution
- The products were shipped to distributor and medical facilities nationwide. The products were also shipped to Taiwan, Germany, Hong Kong, Canada
- Date initiated
- 2010-03-05
- Date posted
- 2010-05-09
- Date terminated
- 2010-12-13
- Location
- Northampton, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLOW CONTROLLER (K843223) | Precision Medical, Inc. | 1984-09-27 |