Neuro Convenience Kit recalled due to expired injectable component
Medline Industries is recalling the Neuro Convenience Kit because a NaCl injectable component expired in April 2020 while the kit's overall expiration date was later. The expired component may pose a safety risk.
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 recall involves an expired injectable component within a medical device kit. Although the expired component poses a potential safety risk, no illnesses or injuries have been reported, placing this at the High severity level per the risk-of-harm rubric criterion.
Plain-English summary
Medline Industries Inc is recalling the Neuro Convenience Kit (Model #DYNJ905194, Lot #19HBK497) due to a component expiration discrepancy. The kit contains a NaCl 250 mL injectable solution that expired in April 2020, while the overall kit's expiration date was after April 2020.
An expired injectable solution may not maintain proper sterility or potency, creating a potential safety risk if administered to patients.
The affected kits were distributed nationwide in the United States. Healthcare facilities and practitioners who have kits from this lot should discontinue use and contact Medline Industries Inc for replacement or return instructions.
The recalled product
- Product
- Neuro Convenience Kit
- Manufacturer
- Medline Industries Inc
- Hazard
- Affected units
- 30
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Medline Industries Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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