Z-0966-2019 Class II Terminated
FDA device recall Z-0966-2019 was initiated by Terumo Cardiovascular Systems Corporation on Dec 20, 2018 and is designated Class II. Reason for recall: Presence of natural rubber latex is not declared in the label The recall status is terminated (terminated Aug 20, 2019). Affected quantity: 12 packs.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2019
- Initiation Date
- Dec 20, 2018
- Termination Date
- Aug 20, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 12 packs
Product Description
Cardiovascular Procedure Kit (CLR MP4 COIL 2 SPIKE) Catalog Number: 140222
Reason for Recall
Presence of natural rubber latex is not declared in the label
Distribution Pattern
TX
Code Information
Lot Numbers: V A30
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0966-2019
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026