Z-0011-2008

Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates

Name: Z-0011-2008 Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
Creator: Pml Microbiologicals Inc.
Published: 2007-08-17
License: https://open.fda.gov/license/

PML, Inc. dba Pml Microbiologicals Inc. / initiated 2007-08-17 / Terminated

FDA source

Pml Microbiologicals Inc. began a recall of Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates on 2007-08-17. The reason FDA records is "Marketed a regulated product without a 510(k)". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0011-2008
Status: Terminated
Initiated: 2007-08-17
Posted: 2007-10-10
Terminated: 2011-06-07
Recalling firm: PML, Inc. dba Pml Microbiologicals Inc.
Product: Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: Marketed a regulated product without a 510(k).
FDA root cause: PMA
Action: Firm notified consignees by phone and fax on August 17, 2007, instructing them to destroy the product.
Quantity in commerce: 1205 plates distributed in US; 1040 distributed in Canada
Distribution: US, Puerto Rico, & Canada
Product codes and lots: PML's catalog #P1174, LOT CODES: 75707-1, 75975-1, 76285-1, 235823-1, 236361-1, 236916-1, 237354-1, 237378-1, 237917-1

Product code JSO

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)