FDA Device recall Z-2334-2024
Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
- FDA Device
- Class II
- ongoing
- Published 2024-07-17
On 2024-07-17 the FDA classified a Class II recall of Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061 by Microspecialties, citing could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2334-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-06-05 |
| Published | 2024-07-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Microspecialties |
| Distribution | MO |
Product
Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic injections Model/Catalog Number: 18061
Reason
Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.
Identifiers
| code_info | UDI: 10841305101071 LOT: P63044983R |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2334-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.