Medical Injection Kit Recall Due to Unconfirmed Sterilization
MICROspecialties is recalling Synergetics I-Pack Injection Kits because some units may not have been properly sterilized, potentially causing post-operative wound 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 an FDA Class II recall involving potential sterilization failure of medical devices used in invasive procedures. No illnesses or injuries have been reported; the hazard is theoretical. Per the rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3.
Plain-English summary
MICROspecialties, Inc. is recalling the Synergetics I-Pack Injection Kit with Drape (Model 18061, LOT P63044983R) used for ophthalmic injections. The recall affects 96 units distributed in Missouri.
The manufacturer could not confirm that the recalled units were exposed to the proper sterilization cycle. Products that have not been properly sterilized can potentially cause post-operative wound infections or injection site infections.
The recalled product
- Product
- Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
- Manufacturer
- MICROspecialties, Inc.
- Hazard
- sterilization-failure
- infection-risk
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: 10841305101071 LOT: P63044983R
Distribution
Distributed in 1 state:
- MO
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