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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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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