EVLP Convenience Pack Recalled for Expired Injectable Component
Medline Industries is recalling EVLP Convenience Pack/Kit due to a NaCl injectable component that expired in April 2020, despite the kit's label showing a later expiration date. Users may unknowingly use expired medication.
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 is an FDA Class II medical device with a component expiration defect and labeling discrepancy. Although no illnesses or injuries have been reported, using an expired injectable medication poses a potential risk of harm, meeting the criteria for High severity.
Plain-English summary
Medline Industries Inc. is recalling the EVLP Convenience Pack/Kit (Model #DYNJ901205C, Lot #19HBE998) distributed nationwide in the United States. The kit includes a 250 mL bag of sodium chloride (NaCl) injectable solution.
The recall was initiated because the NaCl injectable component expired in April 2020, while the kit's printed expiration date is after April 2020. This discrepancy means users may not realize that the injectable inside the kit has already expired and could unknowingly use an expired medication.
Affected users should immediately stop using this kit and verify lot numbers on any EVLP Convenience Packs in their possession. Healthcare facilities should identify and isolate affected units from the recalled lot.
The recalled product
- Product
- EVLP Convenience Pack/Kit
- Manufacturer
- Medline Industries Inc
- Category
- Medical Device — Injectable Kit
- Hazard
- expired-component
- label-mismatch
Distribution
Distributed nationwide across the United States.
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