Cook Inc. Recalls StoneBreaker C02 Cartridges Due to Sterility Concerns
Cook Inc. is recalling 38,542 StoneBreaker C02 Cartridges because the interior may not be sterilized to the appropriate level when reprocessed.
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 3/5 (High).
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, and the hazard involves a potential failure to achieve appropriate sterility in a medical device, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Cook Inc. is recalling 38,542 units of the StoneBreaker C02 Cartridge, Catalog number SBC-10. The recall covers all lots of the product, which is identified by GPN G52603 and UDI (01)10827002526034.
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 defect could potentially affect the safety of the medical device during 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 cartridges should stop using them and contact Cook Inc. for further instructions on how to return or replace the product.
The recalled product
- Product
- StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
- Manufacturer
- Cook Inc.
- Affected units
- 38,542
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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