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

FDA device recall Z-2334-2024 · posted 2024-07-11 · Open, Classified

Recall details

Recalling firm

MICROspecialties, Inc.

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.

Action taken

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: quality@microspecialties.com Contact quality@.microspecialties.com for product return instructions. Please return by 6/25/24. For additional information regarding this please contact quality@.microspecialties.com.

Root cause

Release of Material/Component prior to receiving test results

Status

Open, Classified

Product code

KDD

Quantity affected

96 units

Distribution

MO

Date initiated

2024-06-05

Date posted

2024-07-11

Location

Middletown, CT