Aspen Surgical Products recalls Norton Arm Kits (product code 711400) manufactured between July 2019 and July 2021 due to potential sterilization failure increasing surgical infection risk.
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 Norton Arm Kits made between July 2019 and July 2021 because they may not have been properly sterilized, which could lead to surgical site infections during procedures. This affects medical professionals using these kits in operating rooms.
The kits were manufactured with materials that had higher than acceptable bioburden levels after sterilization. This means the products might not be sterile enough to maintain a clean surgical field, potentially causing infections at the surgical site.
Medical professionals using Norton Arm Kits in operating rooms during surgeries. The risk is highest for patients undergoing procedures where sterile field maintenance is critical.
Check for product code 711400 (previous code 031001) on the kit. These kits were made between July 9, 2019 and July 9, 2021. The sample kit is labeled S711400.
Look for product code 711400 (previous code 031001) on the kit label.
The kits were manufactured with materials that had higher than acceptable bioburden levels after sterilization, which could mean they weren't properly sterilized and might increase surgical infection risk.
The recall record does not specify a remedy or action steps beyond checking the product code. Contact Aspen Surgical Products for further guidance.
The risk is that the kits might not be sterile enough, potentially leading to surgical site infections if used in procedures requiring a sterile field.
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-2390-2021 — Aspen Surgical Products Aspen Surgical Products Hello, I own a Aspen Surgical Products that is covered by recall Z-2390-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
