Reported May 15, 2013 · Terminated
A) Product Code 2N1191: Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use…
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?
- A) Product Code 2N1191Non-DEHP Y-Type Catheter Extension Set, 4.8", Vol. 0.6 mL, Male Luer Lock Adapter, Single use only
- B) Product Code 2N1206Non-DEHP I.V. Catheter Extension Set, 5.7", Vol. 0.7 mL, Male Luer Lock Adapter with Retractable Collar
- Single use only Product UsageThese devices are indicated for use with a vascular access device for administration and withdrawal of fluids
- Lot codes and dates
- A) Product Code 2N1191
Lots R12J06052R12J08041R12K06134R12K08015R12K26108R12K27155
- B) Product Code 2N1206
Lots R12J08124R12J24121R12K01119R12K23089R12K24053R12K22016
- A) Product Code 2N1191
- Amount recalled
- A) Product Code 2N1191: 53,850; B) Product Code 2N1206: 101,900 units
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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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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