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FDA device recall Z-1180-2024 · posted 2024-02-22 · Open, Classified

Recall details

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Reason for recall
There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.
Action taken
Medline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to it consignees on 12/20/2023 via USPS first class mail. The notice explained the problem with the device and requested that the consignee destroy all affected product. Any parties to whom the product was transferred must be notified of the recall communication. For questions, please contact 866-359-1704.
Root cause
Process control
Status
Open, Classified
Product code
LRJ
Quantity affected
1,314,719 units
Distribution
US and territories, S. Korea, Panama, and Dubai
Date initiated
2023-12-20
Date posted
2024-02-22
Location
Northfield, IL

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