Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
This recall is currently active, issued July 11, 2024. It was issued by Microspecialties, Inc..
- Company
- Microspecialties, Inc.
- Recall Initiated
- June 5, 2024
- Posted
- July 11, 2024
- Recall Number
- Z-2334-2024
- Quantity
- 96 units
- Firm Location
- Middletown, CT
- Official Source
- View on FDA website ↗
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.
Distribution
MO
Lot / Code Info
UDI: 10841305101071 LOT: P63044983R
Root Cause
Release of Material/Component prior to receiving test results
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.