Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
FDA Recall Z-2333-2024 · Posted 2024-07-11
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Recalling FirmMICROspecialties, Inc.
Recall StatusOpen, Classified
Product CodeKDD
Date Initiated2024-06-05
Product Quantity2316 units
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.
Firm 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: [email protected]
Contact [email protected] for product return instructions. Please return by 6/25/24.
For additional information regarding this please contact [email protected].
Root Cause
Release of Material/Component prior to receiving test results
Distribution Pattern
MO
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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