Recall Z-2335-2024 ยท KDD Kit, Surgical Instrument, Disposable
MICROspecialties, Inc.
Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
| Date | Jul 11, 2024 (initiated Jun 5, 2024) |
| Status | Open, Classified |
| Reason | Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection. |
| Root cause | Release of Material/Component prior to receiving test results |
| 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: quality@microspecialties.com Contact quality@.microspecialties.com for product return instructions |
| Quantity | 780 units |
| Distribution | MO |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.