FDAClass IIJuly 17, 2024

Synergetics I Pack Injection Kit with Wire Speculum recall

Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W

Why was Synergetics I Pack Injection Kit with Wire Speculum recalled?

Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 10841305101132 LOT: P62764970R

Product
Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
Recalling firm
MICROspecialties, Inc.
Quantity
804 units
Distribution
MO
Recall date
July 17, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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