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).
Recall
- Recall Number
- Z-0960-2019
- Event Number
- 82015
- Firm
- Abbott Vascular
- FEI Number
- 2024168
- Product Code
- MAV
- Status
- Terminated
- Root Cause
- Incorrect or no expiration date
- Initiated
- July 3, 2018
- Address
- 26531 Ynez Rd, Temecula, CA, 92591-4630
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).
Incorrect expiration being entered for one lot.
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.
US Nationwide Distribution - NC and NY
26 units