FDA Medical Device Recalls (openFDA)
Remel, Inc: Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria.
- Recall number
- Z-1733-2009
- Recalling firm
- Remel, Inc
- Product
- Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. Solid Medium recommended for use in qualitative procedures for the isolation and cultivation of mycobacteria.
- Status
- Terminated
- Initiated
- 2009-05-06
- Posted
- 2009-08-14
- Terminated
- 2009-10-15
- Reason
- The plate labeling is incorrect, but the outer box labeling is correct
- Root cause
- Error in labeling
- Action
- The recalling firm issued Important Medical Device Customer Recall Notice letters dated 5/6/08 via regular mail explaining the reason for recall and requesting all remaining inventory of the recalled lot be discarded. A Product Inventory Checklist was enclosed for completion to report the amount of inventory destroyed. A self-addressed postage-paid envelope was enclosed for return of the Product Inventory Checklist. Customers are to contact the firm's Technical Services Department at 800-447-3641 if they have inquiries concerning the letter.
- Quantity
- 118 packages
- Distribution
- Nationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI.
- Lot, serial or model codes
- Lot 763654, Exp. 2009.07.07
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JSY
- 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