Cook Inc. Recalls Pereyra Ligature Carrier 75 Due to Reprocessing Instructions
Cook Inc. is recalling 29 Pereyra Ligature Carrier 75 devices because their reprocessing instructions do not provide sufficient detail for 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 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. The hazard involves insufficient reprocessing instructions for a medical device, which poses a risk of harm (inadequate sterilization) but does not meet the criteria for Class I (death/serious injury) or Class III (unlikely to cause adverse health consequences).
Plain-English summary
Cook Inc. is recalling 29 units of the Pereyra Ligature Carrier 75 (catalog numbers J-PLC-751810 and 090100). The recall was initiated because the reprocessing instructions provided with the devices do not contain sufficient detailed information for the proper cleaning, disinfection, and sterilization of the products.
The affected devices have been distributed nationwide within the United States and in the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
Healthcare facilities and users should contact Cook Inc. for further instructions on how to handle the recalled devices.
The recalled product
- Product
- Pereyra Ligature Carrier 75
- Manufacturer
- Cook Inc.
- Affected units
- 29
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-PLC-751810 and 090100
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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