Reported May 15, 2013 · Terminated
A) Product Code 2N8220: Non-DEHP Catheter Extension Set Kit, Single use only, includes: 1) 7.7", Vol. 1.10 mL, Luer…
Baxter Healthcare Corp.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Baxter Healthcare Corp. · 1 Baxter Pkwy · Deerfield, IL · 60015-4625
Is this the product you have?
24 of 24 products
| Model / number | Product as published |
|---|---|
2N8220 | Non-DEHP Catheter Extension Set Kit, Single use only, includes |
| — | 7.7", Vol. 1.10 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter |
| — | Medium Catheter Stabilization Device, and |
| — | Foam Tape Strips |
2N8221 | Non-DEHP Catheter Extension Set Kit, Single use only, includes |
| — | 7.1", Vol. 0.85 mL, Injection Site Male Luer Lock Adapter with Retractable Collar |
| — | Medium Catheter Stabilization Device, and |
| — | Foam Tape Strips |
2N8222 | Non-DEHP Catheter Extension Set Kit, Single use only, includes |
| — | 8.2", Vol. 0.57 mL, Luer Activated Valve for IV Access, Male Luer Lock Adapter |
| — | Medium Catheter Stabilization Device, and |
| — | Foam Tape Strips |
2N8223 | Non-DEHP Catheter Extension Set Kit, Single use only, includes |
| — | 7.7", Vol. 0.40 mL, Injection Site Male Luer Lock Adapter |
| — | Medium Catheter Stabilization Device, and |
| — | Foam Tape Strips |
6N8220 | V-LINK Luer Activated Device with VITALSHIELD Protective Coating Non-DEHP Catheter Extension Set Kit, Single use only, includes |
| — | 7.6", Vol. 1.0 mL, Catheter Extension Set, Luer Activated Device with Silver for IV Access, Male Luer Lock Adapter with Retractable Collar |
| — | Medium Catheter Stabilization Device, and |
| — | Foam Tape Strips |
- Amount recalled
- A) Code 2N8220: 5,950; B) Code 2N8221: 6,150; C) Code 2N8222: 1,850; D) Code 2N8223: 7,900; E) Code 6N8220: 52,200; F) Code 6N8222: 1,200
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Customers have reported that when separating an individual package from its attached grouping, the adjacent package has opened, compromising its sterile barrier properties.
This product could cause temporary or reversible health problems — stop using it.
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