FDA Medical Device Recalls (openFDA)
Pml Microbiologicals Inc.: Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
- Recall number
- Z-0011-2008
- Recalling firm
- Pml Microbiologicals Inc.
- Product
- Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
- Status
- Terminated
- Initiated
- 2007-08-17
- Posted
- 2007-10-10
- Terminated
- 2011-06-07
- Reason
- Marketed a regulated product without a 510(k).
- Root cause
- PMA
- Action
- Firm notified consignees by phone and fax on August 17, 2007, instructing them to destroy the product.
- Quantity
- 1205 plates distributed in US; 1040 distributed in Canada
- Distribution
- US, Puerto Rico, & Canada
- Lot, serial or model codes
- PML's catalog #P1174, LOT CODES: 75707-1, 75975-1, 76285-1, 235823-1, 236361-1, 236916-1, 237354-1, 237378-1, 237917-1
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSO
- Firm FEI
- 3017344
- Firm city
- Wilsonville
- Firm state
- OR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28