FDA Medical Device Recalls (openFDA)
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).
- Recall number
- Z-0960-2019
- Recalling firm
- Abbott Vascular
- 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).
- Status
- Terminated
- Initiated
- 2018-07-03
- Posted
- not on file
- Terminated
- not on file
- 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
- Lot, serial or model codes
- Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593
- 510(k) numbers
- ["K962495"]
- PMA numbers
- not on file
- Product code
- MAV
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28