Z-0507-2020 Class II Terminated
FDA device recall Z-0507-2020 was initiated by Nucryo Vascular Inc. on October 11, 2019 and is designated Class II. Reason for recall: Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels. The recall status is terminated (terminated May 3, 2021). Affected quantity: 49.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- October 11, 2019
- Termination Date
- May 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49
Product Description
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 working lengths and appropriate balloon diameters and lengths. The balloon has radiopaque markings to assist in balloon placement and to visualize proper expansion of the inflated balloon. The catheter tip is tapered to facilitate entry into peripheral arteries and across lesions. The catheter is designed to be used with appropriately sized guidewires and introducers.
Reason for Recall
Peripheral Dilation Catheters that were E-Beam Sterilized were inadvertently mislabeled with EO sterilized labels.
Distribution Pattern
U.S.: CA, TX, OK, AR, MI, MS. No foreign (OUS) distribution
Code Information
Lots: CAT 0738, CAT 0739, CAT 0740, CAT 0743, CAT 0744, CAT 0746, CAT 0750, CAT 0751, CAT 0758