| Class 2 Device Recall PereyraRaz Ligature Carrier |  |
Date Initiated by Firm | April 25, 2017 |
Create Date | June 14, 2017 |
Recall Status1 |
Terminated 3 on March 26, 2019 |
Recall Number | Z-2534-2017 |
Recall Event ID |
77217 |
Product Classification |
Carrier, ligature - Product Code GEJ
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Product | Pereyra-Raz Ligature Carrier |
Code Information |
All lots Catalog numbers J-RSN-901600 and 090002 |
Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact | Cook Medical Customer Relations Departme 800-457-4500 |
Manufacturer Reason for Recall | reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and
sterilization of these products |
FDA Determined Cause 2 | 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 in Commerce | 257 |
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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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