Windstone Medical recalls sterile saline surgical kits AMS10833 that may not be sterile due to sterility assurance issues. Affected kits have specific lot numbers. Consumers should check their kits and contact the company for details.
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Windstone Medical is recalling certain sterile saline surgical kits because the sterility of the saline cannot be guaranteed. This means the kits might not be sterile, which could lead to infections during medical procedures.
The saline included in these surgical kits may not be sterile due to issues with the sterility assurance process. If the saline is not sterile, it could introduce harmful bacteria into the patient's body during medical procedures, potentially causing infections.
Healthcare professionals and patients using the Aligned Medical Solutions Local Lower Extremity Pack I (AMS10833) with specific lot numbers. Those at highest risk are individuals undergoing surgery where sterile saline is required.
Check the product label for the model number AMS10833 and lot numbers listed: 173719, 176590, 174338, 175529, 176217, 178271, 178489, 180907, 183355, 183674, 184398, 185064, 188137, 189007, 189640, 189641, 189642, 191067, 192551, 196380, 197727, 198046, 198373, 181439, 194252, 199297.
Look for the model number AMS10833 and lot numbers listed in the recall notice.
The sterility of the saline in these surgical kits cannot be guaranteed due to issues with the sterility assurance process.
Check the product label for the model number AMS10833 and lot numbers listed. Contact Windstone Medical for further instructions.
If the saline is not sterile, it could introduce harmful bacteria during medical procedures, potentially causing infections.
We’ve drafted a message you can send Windstone Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1079-2024 — Windstone Medical Windstone Medical Hello, I own a Windstone Medical that is covered by recall Z-1079-2024 from Windstone 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.
