Exact Medical recalls PU and Elastic Blue Bands (6" x 48" with hole) due to lack of 510k clearance for body openings. Affected items have specific lot numbers.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling PU and Elastic Blue Bands (6" x 48" with hole) because they lack FDA 510k clearance for use in natural or surgical body openings. This means the product could pose a risk if used in medical procedures.
The product lacks FDA 510k clearance, meaning it hasn't been approved for use in natural or surgical body openings. This could lead to complications if used in medical procedures where the bands might interact with bodily openings.
Healthcare professionals and medical facilities using these bands for procedures may be affected. Patients using the bands in medical applications are at risk if the product is used without proper clearance.
Check for PU and Elastic Blue Bands that are 6" x 48" with a hole. Affected items have lot numbers: 1909E197, 1910E296, 1911E050, 2002E180, or 2004E028.
Identify if your bands have the lot numbers listed: 1909E197, 1910E296, 1911E050, 2002E180, or 2004E028.
The product lacks FDA 510k clearance for use in natural or surgical body openings, which could pose risks during medical procedures.
Check if your bands have the listed lot numbers. If they do, contact Exact Medical for guidance.
The recall indicates the product hasn't been approved for body use, so it could pose risks even with proper use in medical procedures.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1920-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1920-2021 from Exact Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
