Z-0250-2020 Class II Terminated
FDA device recall Z-0250-2020 was initiated by Cordis Corporation on October 4, 2019 and is designated Class II. Reason for recall: Product was manufactured utilizing an expired inner body. The recall status is terminated (terminated December 14, 2020). Affected quantity: 21 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 6, 2019
- Initiation Date
- October 4, 2019
- Termination Date
- December 14, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21 units
Product Description
Cordis MAXI LD PTA Dilatation Catheter, for cardiovascular use.
Reason for Recall
Product was manufactured utilizing an expired inner body.
Distribution Pattern
US distribution to AL, AZ, FL, MN, and MO
Code Information
Catalog Number: 4171460S; Lot Number: 82169860; Expiry Date: 10/31/2020