Cook Inc. Recalls StoneBreaker Sterilization Caps Due to Sterility Concerns
Cook Inc. is recalling 470 StoneBreaker Sterilization Caps because the interior may not reach the required Sterility Assurance Level during reprocessing.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure to achieve the required Sterility Assurance Level, which poses a risk of harm (infection) to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cook Inc. is recalling 470 units of the StoneBreaker Sterilization Cap (Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020). The recall covers all lots of the product.
The recall was initiated because the interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions provided in the Instructions for Use. This issue could potentially affect the safety of the device during clinical use.
The affected products were distributed nationwide in the United States and in numerous countries internationally, including Australia, Canada, China, Germany, India, and the United Kingdom. Users of these devices should contact Cook Inc. for further instructions on how to proceed.
The recalled product
- Product
- StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
- Manufacturer
- Cook Inc.
- Affected units
- 470
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)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Cook 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.
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