The Recall Desk
HighFDA (Devices)·Z-2535-2017·Announced 2017-06-21

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.

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 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

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 5 products in this recall →