Device product
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).
Z-0960-2019
Product summary
- Firm
- Abbott Vascular
- Event
- Event 82015
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26 units
- Official record key
device-enforcement:Z-0960-2019
Official wording
Reason: Incorrect expiration being entered for one lot.
Code information: Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593
Distribution pattern: US Nationwide Distribution - NC and NY
Derived failure modes
-
Unknown
Incorrect expiration being entered for one lot.