FDA Medical Device Recalls (openFDA)
Pml Microbiologicals Inc.: Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174
- Recall number
- Z-0014-2008
- Recalling firm
- 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
- Status
- Terminated
- Initiated
- 2007-04-23
- Posted
- 2007-10-10
- Terminated
- 2011-06-07
- Reason
- Plates manufactured without vancomycin. Possibility for false resistant results.
- Root cause
- Other
- Action
- On 4/23/07 the firm began contacting customers via fax and telephone.
- Quantity
- 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.
- Lot, serial or model codes
- Lot numbers 229957-1 and 229958-1
- 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