Exact Medical recalls Transducer Cover 15x147cm kits due to lack of FDA 510(k) approval for use in natural or surgical body openings. Affected items include specific lot numbers from 2003-2011.
No 510k for the product to be used in a natural or surgical opening to the body
Exact Medical is recalling Transducer Cover 15x147cm kits because they lack FDA approval for use in body openings. This could lead to serious injury if used incorrectly during medical procedures.
The product has no FDA 510(k) clearance for use in natural or surgical body openings. This means it may not be safe for medical procedures where it could cause injury if used improperly.
Medical professionals using these transducer covers for procedures involving body openings. Patients undergoing procedures with these covers are at risk if the product is used without proper approval.
Check for the item ID E6359 on the kit. Affected lots include 2003E690, 2006E079, 2004E015, 2007E001, 2006E079, 2007E002, 2010E361, 2101E329, and 2011E271.
Look for the item ID E6359 on the transducer cover kit to confirm if it's affected.
No FDA 510(k) approval means it may not be safe for use in body openings, so it should not be used without proper clearance.
Affected lots include 2003E690, 2006E079, 2004E015, 2007E001, 2006E079, 2007E002, 2010E361, 2101E329, and 2011E271.
The recall states the product lacks FDA approval for body use, so it should not be used in medical procedures without proper clearance.
We’ve drafted a message you can send Exact Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1915-2021 — Exact Medical Exact Medical Hello, I own a Exact Medical that is covered by recall Z-1915-2021 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.
