FDA Medical Device Recalls (openFDA)
Abbott Laboratories Diagnostic Div: AEROSET Phenobarbital, LN 1E08-01
- Recall number
- Z-0208-04
- Recalling firm
- Abbott Laboratories Diagnostic Div
- Product
- AEROSET Phenobarbital, LN 1E08-01
- Status
- Terminated
- Initiated
- 2003-11-03
- Posted
- 2004-07-20
- Terminated
- 2004-07-29
- Reason
- Assay is imprecise.
- Root cause
- Other
- Action
- Firm telephoned customers on 11/3/2003 and followed up with a letter offering credit or replacement.
- Quantity
- 112
- Distribution
- Nationwide, Mexico, England and Canada
- Lot, serial or model codes
- Lots: 01066HW00 expires 10/31/2003 06030HW00 expires 4/30/2004 08060HW00 expires 7/31/2004
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LGQ
- Firm FEI
- 2018433
- Firm city
- South Pasadena
- Firm state
- CA
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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