FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
- Recall number
- Z-2514-2023
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
- Status
- Open, Classified
- Initiated
- 2023-08-04
- Posted
- 2023-09-14
- Terminated
- not on file
- Reason
- Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
- Root cause
- Process control
- Action
- Medline issued a recall notice on 08/04/2023 to its consignees by mail and email. The notice explained the problem with the product, risk to use, and requested all affected product be destroyed. Distributors are directed to notify their customers and have the customers document and destroy any affected product. This should be included the customers quantities on the distributor response form.
- Quantity
- 18,000 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- UDI/DI 140267047147818, Lot code 3B085
- 510(k) numbers
- ["K142153"]
- PMA numbers
- not on file
- Product code
- CAF
- 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