SteriTec Steam Biological Test Packs Recalled for Labeling Inaccuracy
SteriTec is recalling 360 units of Steam Biological Test Packs because the readout time does not match the label claims.
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, but the source text identifies the issue as a labeling discrepancy regarding readout time rather than a direct safety hazard or reported injury, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Steritec Products Mfc. Co., Inc. is recalling 360 units of Cardinal BI Stat Biological Test Packs with Instant Readout Integrator (SteriTec Product Code PL 160/A, Distributor Product Code T40311PE). The affected lot number is 130401.
The recall was initiated because Mesa Labs informed SteriTec Products, Inc. that the readout time for the EZTest Steam and Smart-Read Biological Indicators is not in specification with the label claims. These products are steam sterilization monitors designed for biological testing of pre-vacuum steam sterilizers.
The affected units were distributed worldwide, including the United States (nationwide), Argentina, Australia, Canada, the British Virgin Islands, the Czech Republic, Italy, and Turkey. Users should stop using the affected products and contact the manufacturer for further instructions.
The recalled product
- Product
- Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is
- Manufacturer
- Steritec Products Mfc. Co., Inc.
- Hazard
- Affected units
- 360
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 (1)
- Affected Biological Indicator Lot No.:130401
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Steritec Products Mfc. Co., Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Steritec Products Mfc. Co., Inc.
See all →- ModerateSteriTec EZTest Steam Biological Indicator Recalled for Labeling Inaccuracy
FDA (Devices) · 2013-08-07
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- ModerateSteriTec Biological Indicator Test Packs Recalled for Readout Time Issues
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- ModerateSteriTec Steam Biological Test Packs Recalled for Labeling Inaccuracy
FDA (Devices) · 2013-08-07
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