Recall Z-2335-2024— MICROspecialties, Inc.

Class II · Ongoing

Class II FDA medical device recall by MICROspecialties, Inc., initiated 2024-06-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:. Reason: Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection..

Recalling firm
MICROspecialties, Inc.
Classification
Class II
Status
Ongoing
Initiated
2024-06-05
Firm location
Middletown, CT, United States

Product description

Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.