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Open, Classified

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

FDA Recall Z-2334-2024 · Posted 2024-07-11

Recall StatusOpen, Classified
Product CodeKDD
Date Initiated2024-06-05
Product Quantity96 units

Reason for Recall

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

Firm 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].

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

MO

Official Source

View FDA Recall →

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

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