RUSCH IPN050116Recalls & reported problems

Summary

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

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K010420); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Sep 20, 2022Open, Classified

   Product may not be sterile

   Z-0227-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K010420. One submission often covers many models, so check the product and lot details in each record.

• Z-0771-2017 · Nov 22, 2016 · Terminated
  RUSCH, Pocket PAC IC Intermittent Cath Kit, 8 FR, 12 FR, 14 FR, 10 FR and 16 FR, Rx Only, Sterile, Intermittent self-catheterization
• Z-1083-05 · Jul 11, 2005 · Terminated
  Rusch/MMG Urinary Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and un