Recall Z-0960-2019 ยท MAV Syringe, Balloon Inflation
Abbott Vascular
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).
| Date | Jul 3, 2018 |
| Status | Terminated |
| Reason | Incorrect expiration being entered for one lot. |
| Root cause | Incorrect or no expiration date |
| Action | 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. |
| Quantity | 26 units |
| Distribution | US Nationwide Distribution - NC and NY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962495 | INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE) Advanced Cardiovascular Systems, Inc., Sep 12, 1996 |