Ophthalmic Injection Kit Recall Due to Unconfirmed Sterilization
MICROspecialties is recalling the Synergetics I Pack Injection Kit because sterilization cannot be confirmed, potentially causing post-operative wound or injection site infections. Affected units are lot P62764979R distributed in Missouri.
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 of a surgical device where sterilization cannot be confirmed, creating a risk of serious post-operative infections. While no illnesses or injuries have been reported, the theoretical hazard to patients is substantial.
Plain-English summary
MICROspecialties, Inc. is recalling 2,316 units of the Synergetics I Pack Injection Kit- Tray (Model/Catalog Number: 18060), a medical device used for ophthalmic injections. The recalled units are from lot P62764979R.
The manufacturer could not confirm that the products were exposed to the proper sterilization cycle. This sterilization failure creates a potential risk of post-operative wound infections and injection site infections.
The affected units were distributed in Missouri. Healthcare facilities and medical professionals using these injection kits should verify whether they have received units from the recalled lot.
If you have the Synergetics I Pack Injection Kit from lot P62764979R, stop using it immediately. Contact MICROspecialties, Inc. for instructions on returning or disposing of the recalled product.
The recalled product
- Product
- Synergetics I Pack Injection Kit- Tray for use with Ophthalmic injections Model/Catalog Number: 18060
- Manufacturer
- MICROspecialties, Inc.
- Affected units
- 2,316
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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