Medline procedure kits, labeled as: HAND, REF DYNJ902002J
FDA device recall Z-1714-2025 · posted 2025-05-01 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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.
- Action taken
- Medline Industries issued an IMMEDIATE ACTION REQUIRED recall notice to its consignees on 03/19/2025 via email and US mail. The notice explained the issue, potential risk and requested all affected product be destroyed. Credit will be issued upon receipt of completed destruction form. Those who have transferred or further distributed the product were directed to notify those to whom the product was transferred or distributed. For questions contact 866-359-1704 or email Recalls@Medline.com.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- OJH
- Quantity affected
- 159 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- Date initiated
- 2025-03-19
- Date posted
- 2025-05-01
- Location
- Northfield, IL
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