Z-0555-04

BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator

Name: Z-0555-04 BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator
Creator: Instrumentation Industries Inc
Published: 2003-09-12
License: https://open.fda.gov/license/

Instrumentation Industries, Incorporated / initiated 2003-09-12 / Terminated

FDA source

Instrumentation Industries Inc began a recall of BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator on 2003-09-12. The reason FDA records is "possible external debris in the on/off plunger". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0555-04
Status: Terminated
Initiated: 2003-09-12
Posted: 2004-02-27
Terminated: 2004-02-26
Recalling firm: Instrumentation Industries, Incorporated
Product: BE 183 Series Manual Jet Ventilators. Manual Jet Ventilator
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: possible external debris in the on/off plunger.
FDA root cause: Other
Action: The recalling firm notified all customers via telephone to inform them of the problem and the need to return the product when received. The recalling firm issued recall letters dated 9/17/03 to their direct accounts informing them of the problem. The also informed the account that a stop shipment had been ordered but if they receive the product they need to return it immediately.
Quantity in commerce: 46 units
Distribution: The products were shipped to medical facilities in CA, FL, GA, NY, OH, OR, TX, and UT.
Product codes and lots: Part number BE 183-SU, Lot number P0907203

Product code BTM

K991785Class IIManual Jet Ventilator (with Regulator and Gauge), Manual Jet Ventilator (without Regulator and Gauge), Models Be 183-SurInstrumentation Industries, Inc. / cleared 1999-08-17

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)