Ophthalmic injection kit recalled over sterilization confirmation failure
MICROspecialties recalls 780 units of the Synergetics I Pack Injection Kit (Model 18069) because the company could not confirm proper sterilization, creating risk of post-operative or injection-site infections.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II sterile medical device recall where sterilization status could not be confirmed. The potential for serious post-operative or injection-site infections in vulnerable surgical patients qualifies as a risk-of-harm product. Although no illnesses have been reported, the unconfirmed sterilization of an injection device meets the High severity threshold per the rubric.
Plain-English summary
MICROspecialties, Inc. is recalling the Synergetics I Pack Injection Kit Custom-Tray (Model 18069), used for ophthalmic injections. The company could not confirm that affected units were exposed to the proper sterilization cycle. Products that were not properly sterilized can potentially cause post-operative wound infections or injection site infections.
The recall affects 780 units distributed in Missouri. The affected lot number is P62764965R (UDI 10841305101125).
The recalled product
- Product
- Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic injections Model/Catalog Number: 18069 Product Description:
- Manufacturer
- MICROspecialties, Inc.
- Affected units
- 780
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI 10841305101125 LOT: P62764965R
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 4 recalled by MICROspecialties, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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