FDA Recall Open, Classified

Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061

Recall: Z-2334-2024 · Initiated June 5, 2024

Recall

Recall Number
Z-2334-2024
Event Number
94794
Firm
MICROspecialties, Inc.
FEI Number
3002616700
Product Code
KDD
Status
Open, Classified
Root Cause
Release of Material/Component prior to receiving test results
Initiated
June 5, 2024
Posted
July 11, 2024
Address
430 Smith St, Middletown, CT, 06457-1531

Description

Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061

Reason

Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.

Action

MICROspecialties issued Voluntary recall for Synergetics Eye Trays letter on 6/3/24 to the Distributor Synergetics. Letter states reason for recall, health risk and action to take: Review: Inventory for affected product codes Communicate with customers impacted by this notice. Segregate and Quarantine all affected product. Utilize return instructions below Disseminate this notice to any customers who may have been affected. Return the below acknowledgement form by Fax to:860-788-2030 Or email to: [email protected] Contact [email protected] for product return instructions. Please return by 6/25/24. For additional information regarding this please contact [email protected].

Distribution

MO

Quantity

96 units