FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
- Recall number
- Z-2131-2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- MEDLINE NON-STERILE PVP SOLUTION, STERILE PACKAGING REF DYNDA2232A
- Status
- Open, Classified
- Initiated
- 2023-05-18
- Posted
- 2023-07-12
- Terminated
- not on file
- Reason
- Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
- Root cause
- Process control
- Action
- Medline issued a recall notice on 06/02/2023 to its consignees via USPS first class mail. The notice explained the problem with the product and requested the destruction of the product. Medline identified additional products, lots, and consignees and notified their consignees by email on 06/09/2023. Upon receipt of the submitted response form each account will receive over-labels to affix to the affected kits via FedEx overnight, if applicable. distributors were directed to notify their customers and collect the returned product and return it to Medline.
- Quantity
- 183240 units
- Distribution
- Worldwide distribution - US Nationwide and the country of Panama.
- Lot, serial or model codes
- GTIN 10889942851850, Batch Numbers: 2023011090, 2023011190, 2023011790, 2023012090, 2023012590, 2023020790, 2023022390, 2023022490
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- 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