Reported Aug 28, 2024 · Ongoing
Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products…
Microtek Medical 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: Microtek Medical Inc. · 1 Ecolab Pl · Saint Paul, MN · 55102-2739
Is this the product you have?
- Vial Decanter, REF 2006S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50 products to a case (cs).
- Lot codes and dates
- SKU/UDI-Device Identifier2006S/00748426002511
- Lot Numbers
4,648 of 4,648 codes
191216191122211019210916210604210313201017181211181212191211190627190812190617200506190531190618190808210503190609190808191216190609190722190307191015190513190524190703190808190807190531200402190326221029220920220914220427220404220420230612230607231028230320230320221207221027221027221008220926220920220914220909220515211111220322220408211117210708211023210523
- Amount recalled
- 30,435 cases (1,521,750 units)
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was recalled
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
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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