Ophthalmic injection kit recalled due to sterilization process verification failure
MICROspecialties is recalling 804 units of the Synergetics I Pack Injection Kit due to inability to confirm proper sterilization, which could lead to post-operative wound infections or injection site infections.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for a medical device with potential risk of serious infection due to sterilization failure. No illnesses or injuries have been reported, meeting the criterion for 'risk-of-harm products where injury has not yet been reported,' which corresponds to a High severity score.
Plain-English summary
MICROspecialties, Inc. is recalling 804 units of the Synergetics I Pack Injection Kit with Wire Speculum (Model 18069W) used in ophthalmic procedures. The affected lot (P62764970R) was distributed in Missouri.
The recall was initiated because the manufacturer could not confirm that these units were exposed to the proper sterilization cycle. Non-sterile or improperly sterilized injection equipment poses a risk of post-operative wound infection or injection site infection.
Healthcare facilities and medical professionals who received this device should verify they do not have units from the affected lot. Facilities in possession of the identified lot number should contact the manufacturer or their FDA representative for instructions on returning or replacing the affected units.
The recalled product
- Product
- Synergetics I Pack Injection Kit with Wire Speculum- Tray for use in Opthalmic Injection Model/Catalog Number: 18069W
- Manufacturer
- MICROspecialties, Inc.
- Affected units
- 804
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: 10841305101132 LOT: P62764970R
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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