San Jose, CA, United States
Nucryo Vascular Inc. recalls
1 recall recorded since 2018, most recently on 11 October 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 11 October 2019
- Terminated
- 3 May 2021
- Reason
- Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
- Distribution
- U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0507-2020
- The PolarCath Balloon Catheter consists of a coaxial catheter shaft with two concentric, non-compliant balloon systems mounted at the distal tip (balloon within a balloon design). The catheter is available in various wor
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.