Z-0014-2008

Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant...

Name: Z-0014-2008 Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant...
Creator: Pml Microbiologicals Inc.
Published: 2007-04-23
License: https://open.fda.gov/license/

PML, Inc. dba Pml Microbiologicals Inc. / initiated 2007-04-23 / Terminated / root cause: manufacturing process

FDA source

Pml Microbiologicals Inc. began a recall of Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070... on 2007-04-23. The reason FDA records is "Plates manufactured without vancomycin. Possibility for false resistant results". 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-0014-2008
Status: Terminated
Initiated: 2007-04-23
Posted: 2007-10-10
Terminated: 2011-06-07
Recalling firm: PML, Inc. dba Pml Microbiologicals Inc.
Product: Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174
Product code: JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Reason for recall: Plates manufactured without vancomycin. Possibility for false resistant results.
Root cause tag: manufacturing process
FDA root cause: Other
Action: On 4/23/07 the firm began contacting customers via fax and telephone.
Quantity in commerce: 640 total plates, 320 per lot (lot 229957-1 was dist only in Canada; lot 229958-1 was dist in the US and Canada)
Distribution: lot #229957-1: 120 plates were distributed to 9 Canadian consignees; 200 plates were shipped, quarantined, and destroyed at the Canadian distribution center. lot #229958-1: 110 plates were distributed to 9 US consignees; 210 plates were shipped, quarantined, and destroyed at the Canadian distribution center.
Product codes and lots: Lot numbers 229957-1 and 229958-1

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)