Recall Z-2334-2024— 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 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..
- 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 with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
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.