FDA-Device2013-05-15Class II
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.
Baxter Healthcare Corp.
Hazard
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Sold states
Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Affected count
A) Product Code 2N3371: 228,200 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is indicated for use in blood sampling and the administration of solutions. The InterLink Injection Site feature is intended to eliminate accidental needle sticks when used in conjunction with an InterLink Cannula as part of an I.V. needless access system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1269-2013Don't want to check this manually?
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