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.
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 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.
- Affected units
- 96
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:
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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FDA (Devices) · 2024-07-17
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