[pending] Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
Pending LLM rewrite. Source: FDA_DEVICE Z-1710-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 10653160144250 (EA) 40653160144251 (CS)
- Lot Numbers: 23JBU525
Distribution
Distributed nationwide across the United States.
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