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U.S. Department of Health and Human Services

Class 2 Device Recall ARROWgard BluePLUS

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  Class 2 Device Recall ARROWgard BluePLUS see related information
Date Initiated by Firm October 17, 2017
Date Posted February 20, 2018
Recall Status1 Terminated 3 on April 14, 2020
Recall Number Z-0653-2018
Recall Event ID 79197
510(K)Number K071538  
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
Product Pressure Injectable ARROWg+ard Blue PLUS Multi Lumen Central Venous
Catheterization Kit; Product code: ASK-45703-PHF2; Exp. Dates Feb 2018 - Nov 2018
Code Information Lot number: 23F17D0182
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Karen Boylan
610-378-0131
Manufacturer Reason
for Recall		 These finished good kits may contain the incorrect Springwire Guide (SWG).
FDA Determined
Cause 2		 Process control
Action On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.
Quantity in Commerce 5,926 total
Distribution Distribution US Nationwide
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 = FOZ and Original Applicant = ARROW INTERNATIONAL, INC.
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