Z-0960-2019 Class II Terminated
FDA device recall Z-0960-2019 was initiated by Abbott Vascular on Jul 3, 2018 and is designated Class II. Reason for recall: Incorrect expiration being entered for one lot. The recall status is terminated. Affected quantity: 26 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 6, 2019
- Initiation Date
- Jul 3, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26 units
Product Description
PLUS 30 PRIORITY PACK Accessory Kit Product Usage: Is recommended for use during vascular procedures in conjunction with interventional and / or diagnostic devices (e.g., balloon dilatation catheters, atherectomy devices, stent delivery systems, intravascular ultrasound devices).
Reason for Recall
Incorrect expiration being entered for one lot.
Distribution Pattern
US Nationwide Distribution - NC and NY
Code Information
Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0960-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026