Mesa Laboratories recalls ProSpore Biological Indicators with part numbers PS-6-50, PS-5-50, PS-4-10, PS-4-50, and 3471 due to incorrect bromocresol purple concentration. Affected items may not function properly in sterilization processes.
The concentration of bromocresol purple in the recalled lots does not conform to specification.
Mesa Laboratories is recalling specific ProSpore Biological Indicators because the bromocresol purple concentration is incorrect. This could lead to improper sterilization validation in medical settings, potentially affecting patient safety.
The incorrect bromocresol purple concentration may cause the indicators to fail in validating sterilization processes. This could result in inadequate sterilization of medical equipment, potentially leading to infections.
Medical facilities using these ProSpore Biological Indicators for sterilization validation are likely affected. Users in healthcare settings that rely on these indicators for process checks are at the highest risk.
Check for part numbers PS-6-50, PS-5-50, PS-4-10, PS-4-50, or 3471. The recalled items were produced in lots PS-673, PS-674, or PS-675.
Identify the part number and lot number to confirm if the item is recalled.
Part numbers PS-6-50, PS-5-50, PS-4-10, PS-4-50, and 3471 are recalled.
Lots PS-673, PS-674, and PS-675 are affected.
The recall notice does not specify a remedy.
We’ve drafted a message you can send Mesa Laboratories to request your refund or repair — edit it as you like.
Subject: Recall Z-1273-2018 — Mesa Laboratories Mesa Laboratories Hello, I own a Mesa Laboratories that is covered by recall Z-1273-2018 from Mesa Laboratories. 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.
