Synergetics I Pack Injection Kit Custom-Tray for use with… recallZ-2335-2024 · MICROspecialties, Inc. · initiated Jun 5, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MICROspecialties, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
FDA root cause category: Release of Material/Component prior to receiving test results
What the company is doing
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].
Recall details
- Recall number
- Z-2335-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 5, 2024
- Posted by the FDA
- Jul 11, 2024
- Recalling firm
- MICROspecialties, Inc.
- Quantity
- 780 units
- Product code
- KDD
- Distribution
- MO
Product description
Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
Code information (models, lots, serial numbers)
UDI 10841305101125 LOT: P62764965R
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Synergetics 18069Synergetics USA, Inc. · Kit, Surgical Instrument, Disposable2 recalls0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 94794).
- Z-2333-2024 · Open, ClassifiedSynergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
- Z-2334-2024 · Open, ClassifiedSynergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
- Z-2336-2024 · Open, ClassifiedSynergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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