FDA Medical Device Recalls (openFDA)
Cook Inc.: Pereyra Ligature Carrier 75
- Recall number
- Z-2535-2017
- Recalling firm
- Cook Inc.
- Product
- Pereyra Ligature Carrier 75
- Status
- Terminated
- Initiated
- 2017-04-25
- Posted
- not on file
- Terminated
- 2019-03-26
- Reason
- reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products
- Root cause
- Labeling design
- Action
- On 4/25/2017, URGENT: MEDICAL DEVICE RECALL notifications were sent to the affected consignees via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
- Quantity
- 29
- Distribution
- The devices have been distributed nationwide within the United States and 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.
- Lot, serial or model codes
- All lots Catalog numbers J-PLC-751810 and 090100
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GEJ
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28