Z-1561-2010

PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a...

Name: Z-1561-2010 PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selector is attached to a...
Creator: Precision Medical, Inc.
Published: 2010-03-05
License: https://open.fda.gov/license/

Precision Medical, Inc. / initiated 2010-03-05 / Terminated / root cause: labeling and UDI

FDA source

Precision Medical, Inc. began a recall of 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... on 2010-03-05. The reason FDA records is "The on/off outlet is mislabeled so that when a user/operator turns selector to "on", it actually may be turned "off"". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1561-2010
Status: Terminated
Initiated: 2010-03-05
Posted: 2010-05-09
Terminated: 2010-12-13
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.
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
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"
Root cause tag: labeling and UDI
FDA 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 in commerce: 19,518
Distribution: The products were shipped to distributor and medical facilities nationwide. The products were also shipped to Taiwan, Germany, Hong Kong, Canada
Product codes and lots: Lot numbers 1209 and 0110

Product code BTM

K843223Class IIFlow ControllerPrecision Medical, Inc. / cleared 1984-09-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)