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).
FDA Recall Z-0960-2019 · Posted None
Recalling FirmAbbott Vascular
Recall StatusTerminated
Product CodeMAV
Date Initiated2018-07-03
Product Quantity26 units
Reason for Recall
Incorrect expiration being entered for one lot.
Firm 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.
Root Cause
Incorrect or no expiration date
Distribution Pattern
US Nationwide Distribution - NC and NY
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.