FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
- Recall number
- Z-1604-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
- Status
- Open, Classified
- Initiated
- 2025-03-03
- Posted
- 2025-04-17
- Terminated
- not on file
- Reason
- There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Root cause
- Under Investigation by firm
- Action
- An IMMEDIATE ACTION REQUIRED MEDLINE DEVICE RECALL notification letter dated 3/3/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-050-FG Recall Code: RECALL CODE 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers document and destroy any affected product, and include your customer s quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
- Quantity
- 84 kits
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
- Lot, serial or model codes
- 1) DYNJ88422, UDI-DI: 10198459157042(each), 40198459157043(case), Lot Number: 24KBD426
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LRS
- 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