Reported Apr 29, 2015 · Terminated

Bifircated Extension Set, Product Code: BN-828 Accessory device used to administer medical fluids

Churchill Medical Systems, Inc.

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: Churchill Medical Systems, Inc. · 87 Venture Drive · Dover, NH · 03820-5914

Is this the product you have?

  • Bifircated Extension Set
  • Product CodeBN-828 Accessory device used to administer medical fluids
Lot codes and dates
  • 1311080
Amount recalled
100

This recall covers 12 products

The agency filed one notice per product. You are reading one of them; the other 11 are below.

Where it was sold

Why it was recalled

Potential for leaking caused by insufficient bond between needleless device and female luer.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Feb 25, 2016 · Data as of Sep 19, 5:30 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.