Medline I&D Procedure Kits Recalled for Leaking Saline Bottles
Medline is recalling 240 units of NON STERILE I&D KIT (Lot 23KDB283) distributed in the US, Panama, and Canada. The Sterile Water and Normal Saline bottles in the kits are leaking at the peel-foil interface, compromising sterility.
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: This FDA Class II medical device has sterile bottles leaking at the peel-foil interface, compromising sterility in medical procedures. With no reported illnesses or injuries, this is a risk-of-harm product where injury has not yet been reported, meeting the Score 3 (High) criterion.
Plain-English summary
Medline Industries is recalling its NON STERILE I&D KIT (Reference DYKM1438, Lot Number 23KDB283) in a quantity of 240 units. The product has been distributed worldwide, including the United States, Panama, and Canada.
The recall was initiated because Sterile Water and Sterile 0.9% Normal Saline bottles contained in the kit are leaking at the interface of the peel-foil and bottle opening. This affects healthcare facilities, providers, and patients who may use or have used these kits in medical procedures.
Healthcare facilities and providers who have received this product should discontinue use immediately and contact Medline Industries for replacement kits. Patients who may have received medical procedures involving these kits should consult their healthcare provider if they have concerns.
The recalled product
- Product
- Medline procedure kits, labeled as: NON STERILE I&D KIT, REF DYKM1438
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure kit
- Hazard
- product-leakage
- sterility-compromise
- contamination-risk
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 10889942529964 (EA) 40889942529965 (CS)
- Lot Numbers: 23KDB283
Distribution
Distributed nationwide across the United States.
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