Sharp Medical Products recalls Reactor and Sleeve REF 100-36-0: non-sterile barrier holes/punctures risk infection. Affected units have lot number 0818-009.
Non-conformity (holes/punctures or deep creases) in the sterile barrier.
Sharp Medical Products is recalling their Reactor and Sleeve REF 100-36-01 (adult size) due to holes or deep creases in the sterile barrier. This defect could allow contamination and infection during medical procedures.
The sterile barrier may develop holes or deep creases, compromising its ability to prevent contamination. This could lead to infections during medical procedures if the device is used without proper sterility.
Healthcare professionals using the Reactor and Sleeve for medical procedures. Patients receiving procedures with this device are at risk of infection.
Check for the product name 'Reactor and Sleeve', model REF 100-36-01, adult size. Affected units have lot number 0818-009.
Identify the product name, model REF 100-36-01, adult size, and lot number 0818-009.
The recall indicates a potential risk of contamination due to holes or creases in the sterile barrier, so it should not be used until the recall is addressed.
Check for the product name 'Reactor and Sleeve', model REF 100-36-01, adult size, and lot number 0818-009.
The recall does not specify a remedy, so contact Sharp Medical Products for guidance.
We’ve drafted a message you can send Sharp Medical Products to request your refund or repair — edit it as you like.
Subject: Recall Z-1366-2021 — Sharp Medical Products Sharp Medical Products Hello, I own a Sharp Medical Products that is covered by recall Z-1366-2021 from Sharp Medical Products. 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.
