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FDAFDA · Food and drugs·Recall number Z-1270-2013

A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; B) Product Code 2N8221: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.1", Vol. 0.85 mL, Injection Site Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; C) Product Code 2N8222: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2", Vol. 0.57 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; D) Product Code 2N8223: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 0.40 mL, Injection Site Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; E) Product Code 6N8220: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.6", Vol. 1.0 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter with Retractable Collar, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips; F) Product Code 6N8222: V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 8.2", Vol. 0.5 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter, 2) Medium Catheter Stabilization Device, and 3) Foam Tape Strips Product Usage: The IV extension tubing kits are intended to provide users with a ready to use set up for the administration and withdrawal of fluids avoiding the need to acquire/assemble components from various manufacturers. The IV extension tubing sets are indicated for use with a vascular access device for administration and withdrawal of fluids.

Published May 15, 2013 · Recall initiated: March 28, 2013

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Baxter Healthcare Corp.
Distributor
Worldwide Distribution - USA Nationwide and the countries of Puerto Rico, Brazil, Canada and Columbia.
Lot
A) Product Code 2N8220: Lots R12J05070; B) Product Code 2N8221: Lots R12J20046, R12J22042; C) Product Code 2N8222: Lots R12L07031; D) Product Code 2N8223: Lots R12L06074, R12K02083; E) Product Code 6N8220: Lots R12I01054, R12H25048, R12H27192, R12J04057, R12J22109, R12L07049, R12L08088; F) Product Code 6N8222: Lots R12J15046, R12J23115
Risk classification
Class II
Area (FDA)
device
Country
United States

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