FDA Medical Device Recalls (openFDA)
Remel Inc: CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
- Recall number
- Z-0209-2018
- Recalling firm
- Remel Inc
- Product
- CM0405 Mueller-Hinton Broth IVD, 500g makes 23.8 litres.
- Status
- Terminated
- Initiated
- 2017-11-02
- Posted
- not on file
- Terminated
- 2020-08-05
- Reason
- Product may have incorrect cation information detailed on the product label.
- Root cause
- Under Investigation by firm
- Action
- The recalling firm issued letters dated 11/2/2017 via regular mail on 11/2/2017 notifying the customer of the incorrect labeling information and providing them the correct labeling information.
- Quantity
- 7 units
- Distribution
- Distribution was made to AL, MD, ME, NC, and TN. There was no foreign/military/government distribution.
- Lot, serial or model codes
- Lot 1865331, Exp. 06/2021
- 510(k) numbers
- ["K802498"]
- PMA numbers
- not on file
- Product code
- JTZ
- Firm FEI
- 1924669
- Firm city
- Lenexa
- Firm state
- KS
- 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