Reported Jan 30, 2013 · Terminated

Medisystems 15 Gauge x 3/5 inch Buttonhole Needle Set Product Code: BH-2035PE Product Usage: Medisystems Buttonhole…

Medisystems a NX Stage Company

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: Medisystems a NX Stage Company · 350 Merrimack St · Lawrence, MA · 01843-1748

Is this the product you have?

  • Medisystems 15 Gauge x 3/5
  • inch Buttonhole Needle Set Product CodeBH-2035PE
  • Product UsageMedisystems Buttonhole Needle Sets are indicated for use as an access device for dialysis and pheresis procedures using a constant site orbuttonhole method of needle insertion
Lot codes and dates
  • Lot120719F4
Amount recalled
26 casesx 250 needles (6500needles)

This recall covers 2 products

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

Where it was sold

Why it was recalled

A total of 5 (ea) single needle pouches are mislabeled as 15 Ga x1" instead of 15 Ga x 3/5".

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 Oct 10, 2013 · Data as of Sep 19, 6:51 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.