Atlas FDA

Syringes labeled as: a) SYR 10ML L/L CONTROL, Item Numbers: 1. DNSC91881, 2. DYNJSYRPPC10; b) SYRINGE 20ML BLUE L/L LOW

FDA device recall Z-1936-2024 · posted 2024-05-31 · Open, Classified

Recall details

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Reason for recall
These syringes were identified to be affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and other quality issues have been identified that may pose a risk to patient health.
Action taken
Medline Industries, LP issued a recall notice to its consignees on 04/17/2024 via USPS, First Class mail. The notice explained the issue, potential risk to the user, and requested the consignee destroy all affected product. If the product was further distributed, the party distributing the affected product was directed to notify their customers.
Root cause
Under Investigation by firm
Status
Open, Classified
Product code
FMF
Quantity affected
2,348,430 syringes
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Date initiated
2024-04-17
Date posted
2024-05-31
Location
Northfield, IL

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