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).
This recall has been terminated (originally issued July 3, 2018).
- Company
- Abbott Vascular
- Recall Initiated
- July 3, 2018
- Recall Number
- Z-0960-2019
- Quantity
- 26 units
- Firm Location
- Temecula, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect expiration being entered for one lot.
Distribution
US Nationwide Distribution - NC and NY
Lot / Code Info
Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593
Root 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.