Steris Recalls Verify Bowie-Dick Test Cards Due to Performance Issues
Steris Corporation is recalling Verify Bowie-Dick Test Cards because they may produce false fail results, potentially indicating sterilizer issues when performance is actually acceptable.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 false negative results (false fails) in sterilization testing, which is a significant quality issue but does not involve direct physical injury or death to patients, fitting the criteria for a moderate severity recall involving performance defects.
Plain-English summary
Steris Corporation is recalling 629 Verify Bowie-Dick Test Cards, Model #S3098, due to performance issues. The affected cards are identified by serial numbers H20013, H20014, and H20016. These test cards are used to evaluate the effectiveness of air removal from sterilizer chambers during prevacuum pulse steam sterilizer cycles.
The recall was initiated because the test cards are not performing to product specifications. Specifically, the cards have resulted in false fail results when sterilizer performance is within acceptable ranges. This means the cards may indicate that a sterilization cycle was inadequate even when the sterilizer was functioning correctly.
The affected products were distributed nationwide in the United States and in Canada. Users of these test cards should check their inventory for the specific model and serial numbers listed in this recall. If you have these cards, you should stop using them and contact Steris Corporation for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Verify¿ Bowie-Dick Test Card, Model #S3098, Steris Biological Operations, 9325 Pinecone Drive, Mentor, OH 44060 The Verify Bowie-Dick Test Card consists of a card printed on one side with bars of chemical indicator ink. On the opposite side of the card, space is provided for…
- Manufacturer
- Steris Corporation
- Affected units
- 629
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 (4)
- Model #S3098
- Serial #"s: H20013
- H20014
- and H20016.
Distribution
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