FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Namic FLUID DELIVERY SET, REF 91300040
- Recall number
- Z-1807-2024
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Namic FLUID DELIVERY SET, REF 91300040
- Status
- Open, Classified
- Initiated
- 2024-03-12
- Posted
- 2024-05-10
- Terminated
- not on file
- Reason
- Products have a lack of sterility assurance.
- Root cause
- Process control
- Action
- Medline issued a Medical Device Recall notice to its consignees on 03/12/2024 via email and US Mail. The notice explained the issue, potential risk, and requested destruction of the affected product. Those who further distributed the product were directed to notify those to whom they shipped the product.
- Quantity
- 50 units
- Distribution
- US Nationwide distribution in the states of AL, FL, KY, MS, TX, WA, WI, NC, VA, CA, SD, TN, GA, PA, TX.
- Lot, serial or model codes
- UDI/DI 20193489069096 (box), 10193489069099 (unit), Lot Numbers: 0000113381
- 510(k) numbers
- K852140
- PMA numbers
- not on file
- Product code
- FPA
- 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