PlainRecalls
FDA Devices Moderate Class II Terminated

A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.

Reported: May 15, 2013 Initiated: March 28, 2013 #Z-1268-2013

Product Description

A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.

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 2N1191: 53,850; B) Product Code 2N1206: 101,900 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 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only; B) Product Code 2N1206: Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar, Single use only Product Usage: These devices are indicated for use with a vascular access device for administration and withdrawal of fluids.. Recalled by Baxter Healthcare Corp.. Units affected: A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 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-1268-2013.

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