FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
- Recall number
- Z-1429-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- namic convenience kits labeled as: KIT,ARTERIAL,60,(152CM),PG; medical convenience kit, REF 70036160
- Status
- Open, Classified
- Initiated
- 2025-02-12
- Posted
- 2025-03-21
- Terminated
- not on file
- Reason
- The female luer fittings on the Pressure Monitoring Lines (PMLs) were manufactured with excess material near the fluid pathway.
- Root cause
- Process change control
- Action
- Medline Industries issued two notices, delivered using email and US Mail: 1) a MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines and 2) a MEDICAL DEVICE RECALL notice for the kits containing the affected product; both notices explained the issue and the hazard. The MEDICAL DEVICE RECALL notice for the affected Pressure Monitoring Lines requested that the consignee destroy any affected inventory and reply to receive credit. The MEDICAL DEVICE RECALL notice for the kits containing the affected product requested the consignee respond to the notice and upon response, Medline will provide labeling that states the following: "ATTENTION This kit contains a recalled item Medline Pressure Monitoring Lines VPN: 24614303 DO NOT USE THIS COMPONENT The rest of the kit may be used. Please remove this item only and replace with product from supply. *Do not cover or remove this sticker*" Consignees were directed to notify their customers of these actions.
- Quantity
- 40 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of The Netherlands, New Zealand, Slovakia
- Lot, serial or model codes
- UDI/DI 10193489064803 (each), 20193489064800 (case), Lot number 0000140054
- 510(k) numbers
- ["K910764"]
- PMA numbers
- not on file
- Product code
- DRS
- 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