FDA Enforcement
Class II
Terminated
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Recall: Z-0250-2020
·
Reported November 6, 2019
Enforcement
- Recall Number
- Z-0250-2020
- Event ID
- 83977
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cordis Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 6, 2019
- Initiation Date
- October 4, 2019
- Classification Date
- October 30, 2019
- Termination Date
- December 14, 2020
- Address
- 14201 NW 60th Ave, Miami Lakes, FL, 33014-2802, United States
Description
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Reason
Product was manufactured utilizing an expired inner body.
Code Info
Catalog Number: 4171460S; Lot Number: 82169860; Expiry Date: 10/31/2020
Distribution
US distribution to AL, AZ, FL, MN, and MO
Quantity
21 units