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U.S. Department of Health and Human Services

Class 2 Device Recall Synergetics

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 Class 2 Device Recall Synergeticssee related information
Date Initiated by FirmJune 05, 2024
Date PostedJuly 11, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2335-2024
Recall Event ID 94794
Product Classification Kit, surgical instrument, disposable - Product Code KDD
ProductSynergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
Code Information UDI 10841305101125 LOT: P62764965R
Recalling Firm/
Manufacturer		 MICROspecialties, Inc.
430 Smith St
Middletown CT 06457-1531
For Additional Information Contactsame
203-874-1832 Ext. 130
Manufacturer 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.
FDA Determined
Cause 2		Release of Material/Component prior to receiving test results
ActionMICROspecialties 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.
Quantity in Commerce780 units
DistributionMO
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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