Z-1947-2016 Class II Terminated
FDA device recall Z-1947-2016 was initiated by Cordis Corporation on May 4, 2016 and is designated Class II. Reason for recall: Inability to deploy the stent or partial stent deployment. The recall status is terminated (terminated Jul 26, 2019). Affected quantity: 4,400 units in US; 3,100 units to Foreign Countries.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 22, 2016
- Initiation Date
- May 4, 2016
- Termination Date
- Jul 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,400 units in US; 3,100 units to Foreign Countries
Product Description
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)
Reason for Recall
Inability to deploy the stent or partial stent deployment.
Distribution Pattern
NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
Code Information
Catalog Number: P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number: 17241838; Catalog Number: P07030RXB, Lot Number : 17291878; Catalog Number: P07040RXB, Lot Number: 17291879; Catalog Number: P06040RXB, Lot Number: 17415243.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1947-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026