Aspen Surgical Products recalls Jessie Sterile Arm Suspension Kit (product codes 711300 and 100401) manufactured between July 2019 and July 2021 due to potential sterilization failure. Affected kits may increase surgical site infection risk if used without proper sterility.
Affected products were manufactured with materials found to have a bioburden level exceeding the limit at which the product's sterilization process was validated. As a result, the firm cannot provide full assurance that the affected products were effectively sterilized, and the product may compromise a sterile field and increase the risk of a surgical site infection.
Aspen Surgical Products is recalling Jessie Sterile Arm Suspension Kits made between July 2019 and July 2021 because they might not be properly sterilized. This could lead to surgical site infections if used in medical procedures.
The kits were made with materials that didn't meet sterilization standards. This means the kits might not be sterile enough to prevent infections during surgery, potentially causing surgical site infections.
Healthcare professionals using the kits for surgical procedures are most at risk. Patients undergoing surgery with these kits could face increased infection risks.
Check for product code 711300 (or previous code 100401) on the kit. The kits were sold between July 9, 2019 and July 9, 2021.
Look for product code 711300 or previous code 100401 on the kit.
The kits were manufactured with materials that may not have been properly sterilized, increasing the risk of surgical site infections.
The official recall notice does not specify a remedy or action step for affected kits.
The kits were manufactured between July 9, 2019 and July 9, 2021.
We’ve drafted a message you can send Aspen Surgical Products to request your refund or repair — edit it as you like.
Subject: Recall Z-2388-2021 — Aspen Surgical Products Aspen Surgical Products Hello, I own a Aspen Surgical Products that is covered by recall Z-2388-2021 from Aspen Surgical 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.
