Reported Sep 24, 2014 · Terminated
Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and…
Genesis BPS, LLC.
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: Genesis BPS, LLC. · 65 Commerce Way · Hackensack, NJ · 07601-6302
Is this the product you have?
- Pedi-Pak Pedi-Syringe Filter 30 mL Becton Dickinson Syringe Rx Only Genesis BPS, LLC The intended use is to prepare and deliver small aliquots of filtered whole blood, red blood cells, platelets, plasma, and cryoprecipitate for pediatric and or neonatal transfusion
- Lot codes and dates
Cat #405-530BD Lot #3640-234763640-235063640-241533640-242063640-243983640-244853640-245173640-239693640-243303640-24521
- Amount recalled
- 7560 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Genesis BPS is recalling numerous devices since they did not notify the agency of its intent to introduce material changes.
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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