FDA Medical Device Recalls (openFDA)
EMD Millipore Corporation: Lugol s Iodine Solution 500ML, Part Number 624-71
- Recall number
- Z-0408-2024
- Recalling firm
- EMD Millipore Corporation
- Product
- Lugol s Iodine Solution 500ML, Part Number 624-71
- Status
- Open, Classified
- Initiated
- 2023-10-17
- Posted
- 2023-11-29
- Terminated
- not on file
- Reason
- Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.
- Root cause
- Under Investigation by firm
- Action
- A Product Recall notification letter dated 10/17/23 was sent to customers. Required/Recommended Action Please immediately examine your inventory to determine if you have any remaining impacted product and forward a copy of this letter to the personnel in your organization that utilize this product and/or need to be made aware of this issue. Please discard this material and request a replacement. Please complete attachment 1 form acknowledging receipt of this letter and return to the noted email address. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this issue. Your notification to customers should include a copy of this notification. You may contact Technical or Customer Service to discuss an appropriate solution for your needs. If you would like more information about this FCA notification, please contact your local representative or use the link www.sigmaaldrich.com/offices for our website to obtain the phone number and/or email address of your local office.
- Quantity
- 5 units
- Distribution
- US States: CA, NJ, WV
- Lot, serial or model codes
- Lot Number 3124
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IAM
- Firm FEI
- 2244894
- Firm city
- Burlington
- Firm state
- MA
- 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