Z-1232-04

Boehringer Replacement Gauge Model 9071, Lot Number 200405

Name: Z-1232-04 Boehringer Replacement Gauge Model 9071, Lot Number 200405
Creator: Boehringer Laboratories Inc
Published: 2004-05-19
License: https://open.fda.gov/license/

Boehringer Laboratories, LLC / initiated 2004-05-19 / Terminated / root cause: manufacturing process

FDA source

Boehringer Laboratories Inc began a recall of Boehringer Replacement Gauge Model 9071, Lot Number 200405 on 2004-05-19. The reason FDA records is "The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1232-04
Status: Terminated
Initiated: 2004-05-19
Posted: 2004-07-20
Terminated: 2004-09-14
Recalling firm: Boehringer Laboratories, LLC
Product: Boehringer Replacement Gauge Model 9071, Lot Number 200405.
Product code: GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Reason for recall: The suction regulator incorporates a gauge for the verification of suction levels. The particular lot of gauges used in the production of the regulators exhibits a potential to develop a leak and cause the delivered suction to be inaccurate.
Root cause tag: manufacturing process
FDA root cause: Other
Action: All direct accounts were contacted by the recalling firm''s Customer Service Representative to determine the location of the affected product. The CSR arrange for replacement proudct.
Quantity in commerce: 9 units
Distribution: The recalled product was distributed to the following states: AL, FL, MA, MI, OR, PA, TN,
Product codes and lots: Lot Number 200405

Product code GCX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)