Reported Aug 28, 2024 · Ongoing
C-Flow Bag Decanter, REF 2000S. 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?
- C-Flow Bag Decanter, REF 2000S. 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 Identifier2000S/00748426002085
- Lot Numbers
4,649 of 4,649 codes
190220200424200424191214191025191118211024210602211016211016210912211024210912210912210912210727210828210608210608210411210411210323210118210113210113201123201009200423190429200619190719191025190614190715190614200424190614200619200914191225191027191106181005190715181123190429190606181207190220190805190503190304200331181207200914200914190606191209190719191225
- Amount recalled
- 10,366 cases (518,300 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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