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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