Recall Z-0960-2019
Abbott Vascular · initiated July 3, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593
Reason for recall
Incorrect expiration being entered for one lot.
FDA-determined cause: Incorrect or no expiration date
Action taken
Abbott Vascular sent an Urgent Field Safety Notice/ Device Recall letter dated July 3, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to: " Review inventory and stop using affected devices. " Complete and return the attached Effectiveness Check Form " Return the unused identified products to Abbott Vascular " Share this notification with other relevant personnel in their organization For questions contact Abbott Representative or Customer Service department on 800-227-9902.
Details
- Recall number
- Z-0960-2019
- Initiated
- July 3, 2018
- Product code
- MAV – Syringe, Balloon Inflation
- Quantity
- 26 units
- Distribution
- US Nationwide Distribution - NC and NY
- Recalling firm
- Abbott Vascular, Temecula, CA