Measurement Specialties Reusable Temperature Probes Recalled for Unvalidated Sterilization Instructions
Measurement Specialties Inc. is recalling 6,076 reusable temperature probes because their sterilization instructions have not been proven through a validation study.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves unvalidated sterilization instructions, which is a procedural or documentation issue rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Measurement Specialties Inc. is recalling 6,076 Reusable Temperature Probe Autoclavable devices. The products are sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) probes. They are intended for use by licensed physicians to continuously monitor human esophageal, rectal, or skin temperature and are designed to be used with patient monitoring systems that accept 400 Series temperature probes.
The recall was initiated because the reusable temperature probes are provided with instructions for sterilization that have not been proven through a validation study. The affected devices include Part No. 401AC, 402AC, and 409AC across various lot numbers.
The devices were distributed nationwide in the United States to the states of AL, CA, KY, IL, KS, MN, NY, OH, TX, VA, and WI. They were also distributed internationally to Australia, Canada, China, England, Germany, India, Ireland, Israel, Italy, Japan, Malaysia, Netherlands, Singapore, South Africa, South Korea, Taiwan, and Vietnam. Users should contact Measurement Specialties Inc. for further instructions regarding the recall.
The recalled product
- Product
- Measurement Specialties Reusable Temperature Probe Autoclavable. Sold as Esophageal/Rectal (Adult), Esophageal/Rectal (Pediatric), and Skin (Adult) Intended for use by a licensed physician to continuously monitor human esophageal, rectal, or skin temperature. They are designe
- Manufacturer
- Measurement Specialties Inc
- Affected units
- 6,076
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part No. 401AC (Lot No. 14K87246
- 15M96863
- 13E72645
- 12D61386
- 13D72302
- 16B97593
- 15C91286
- 13B64377
- 14J86547
- 12B59416
- 13A69334
- 15K95972
- 15A97196
- 15E92377
- 15F92378
- 13L77336
- 12D61023
- 14G84704
- 14K87499
- 14F84193
Distribution
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