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Synergetics 18061Recalls & reported problems

Synergetics USA, Inc. · I-PACK Injection Kit with Drape · Class 1

2 open recalls name this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
2

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier, 2 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Jun 12, 2024Open, Classified

    Sterilization certificates could not be validated by the supplier

    Z-2252-2024 · Root cause: Under Investigation by firm · FDA record ↗

  2. Jun 5, 2024Open, Classified

    Could not confirm products were exposed to the proper sterilization cycle can potentially cause post operative wound infection or injection site infection.

    Z-2334-2024 · Root cause: Release of Material/Component prior to receiving test results · FDA record ↗

Other Kit, Surgical Instrument, Disposable devices

All Kit, Surgical Instrument, Disposable devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.