Cook Inc. Recalls Pereyra-Raz Ligature Carriers Due to Inadequate Reprocessing Instructions
Cook Inc. is recalling 257 Pereyra-Raz Ligature Carriers because the provided reprocessing instructions do not contain sufficient detail for proper cleaning, disinfection, and sterilization.
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 is a labeling/instruction deficiency that may lead to improper reprocessing, but the source text does not report any specific illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cook Inc. is voluntarily recalling 257 units of the Pereyra-Raz Ligature Carrier. The recall was initiated because the reprocessing instructions provided with the devices do not offer sufficient detailed information for the cleaning, disinfection, and sterilization of the products.
The affected devices are identified by catalog numbers J-RSN-901600 and 090002. These products were distributed nationwide within the United States and in several international locations, including Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, the Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
Healthcare facilities and users should stop using the affected devices and contact Cook Inc. for further instructions regarding the recall and potential replacement or refund.
The recalled product
- Product
- Pereyra-Raz Ligature Carrier
- Manufacturer
- Cook Inc.
- Affected units
- 257
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 Catalog numbers J-RSN-901600 and 090002
Distribution
Part of a larger recall action
This product is one of 5 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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