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U.S. Department of Health and Human Services

Class 2 Device Recall Plus 30 PRIORITY PACK (Accessories Kits)

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  Class 2 Device Recall Plus 30 PRIORITY PACK (Accessories Kits) see related information
Date Initiated by Firm July 03, 2018
Create Date February 27, 2019
Recall Status1 Terminated 3
Recall Number Z-0960-2019
Recall Event ID 82015
510(K)Number K962495  
Product Classification Syringe, balloon inflation - Product Code MAV
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).
Code Information Device Identifier #: 08717648 01360 7 Part Number: 1000185 Lot number: 60047593
Recalling Firm/
Manufacturer		 Abbott Vascular
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact Customer Service
800-227-9902
Manufacturer Reason
for Recall		 Incorrect expiration being entered for one lot.
FDA Determined
Cause 2		 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 in Commerce 26 units
Distribution US Nationwide Distribution - NC and NY
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MAV and Original Applicant = ADVANCED CARDIOVASCULAR SYSTEMS, INC.
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