Exact Medical recalls 6" x 48" Elastic Poly Probe Cover (Item ID: A-AU-0852NA) due to lack of 510k clearance for medical use. Affected units include specific lot numbers.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling a 6" x 48" elastic poly probe cover because it lacks FDA 510(k) clearance for use in natural or surgical body openings. This means the product may not be safe for medical procedures.
The product lacks FDA 510(k) clearance, which is required for medical devices to be used in body openings. Without this clearance, the device may not meet safety standards for medical use, potentially causing harm during procedures.
Medical professionals who use this probe cover for procedures are likely affected. Patients using the product for medical purposes could be at risk if the cover is used without proper clearance.
Check for the product name '6" x 48" Elastic Poly Probe Cover, T Tip, Tele Fold, 2 bands' with Item ID A-AU-0852NA. Affected units have specific lot numbers: 1912E126, 2002E133, 2008E227, 2008E226.
Identify the product name and lot numbers to confirm if it is affected.
The recall states the product lacks FDA 510(k) clearance for use in body openings, so it is not approved for medical procedures.
Affected lot numbers are 1912E126, 2002E133, 2008E227, and 2008E226.
The recall does not specify a remedy, so there is no immediate action required beyond checking if the product is affected.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1909-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1909-2021 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.
