FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1561-2010
- Recalling firm
- Precision Medical, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2010-03-05
- Posted
- 2010-05-09
- Terminated
- 2010-12-13
- 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
- Lot, serial or model codes
- Lot numbers 1209 and 0110
- 510(k) numbers
- ["K843223"]
- PMA numbers
- not on file
- Product code
- BTM
- Firm FEI
- 2523148
- Firm city
- Northampton
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28