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Terminated

Pereyra-Raz Ligature Carrier

FDA Recall Z-2534-2017 · Posted None

Recalling FirmCook Inc.
Recall StatusTerminated
Product CodeGEJ
Date Initiated2017-04-25
Date Terminated2019-03-26
Product Quantity257

Reason for Recall

reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products

Firm 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.

Root Cause

Labeling design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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