Recall Z-1708-2025— MEDLINE INDUSTRIES, LP - Northfield
Class II · Ongoing
Class II FDA medical device recall by MEDLINE INDUSTRIES, LP - Northfield, initiated 2025-03-19. FDA's recall record names no specific 510(k) clearance for this event. Product: Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438. Reason: It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening..
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-03-19
- Firm location
- Northfield, IL, United States
Product description
Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
Reason for recall
It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
Data sourced from openFDA. This site is unofficial and independent of the FDA.