Reported Aug 28, 2024 · Ongoing
Bottle Decanter, REF 2004S. Packaged on a form, fill and seal machine with a poly/Tyvek material then placed 50…
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?
- Bottle Decanter, REF 2004S. 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 Identifier2004S/00748426002498
- Lot Numbers
382 of 382 codes
200328220321220321221220221220221102220321181127220321210506200328181127200328181127181127181127200328200328180625191113220321220321220321220321210506210506210109191113200328201115200328181127181127200328181127181127181127210506191113191113180625181127221220221102220321181127220321210506210506191113200328220321220321220321200328220321220321210506210506221220
- Amount recalled
- 163 cases (8,150 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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