PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 15, 2013 Initiated: March 28, 2013 #Z-1269-2013

Product Description

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.

Reason for Recall

Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.

Details

Recalling Firm
Baxter Healthcare Corp.
Units Affected
A) Product Code 2N3371: 228,200 units
Distribution
Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Location
Deerfield, IL

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Baxter Healthcare Corp.. Units affected: A) Product Code 2N3371: 228,200 units.
Why was this product recalled? ▼
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2013. Severity: Moderate. Recall number: Z-1269-2013.

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