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U.S. Department of Health and Human Services

Class 2 Device Recall Access Tray

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  Class 2 Device Recall Access Tray see related information
Date Initiated by Firm January 11, 2017
Create Date February 22, 2017
Recall Status1 Terminated 3 on September 06, 2018
Recall Number Z-1228-2017
Recall Event ID 76237
510(K)Number K930129  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product Vascular catheter introduction kit
The PICC is indicated for short or long term peripheral access to the central Venous system for intravenous therapy, blood sampling, infusion and power injection of contrast media.
Code Information Material #  ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01552-LS, PI-01552-LS5, PI-01552-SS, PL-05041, PL-05041, PL-05052, PR-05041, PR-05041, PR-05041-T, PR-05042, ASK-01663-MST, ASK-04001-DU4, ASK-04001-DU5, PI-01351-LS, PI-01351-LS5, PI-01351-SS, PI-01351-SS, PI-01451-LS, PI-01451-LS5, PI-01451-SS, PI-01451-SS, PI-0-1552-LS
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact
610-378-0131
Manufacturer Reason
for Recall		 There have been complaints for peel away sheaths flaring
FDA Determined
Cause 2		 Device Design
Action Arrow International mailed an Urgent Medical Device Advisory Notification letter to affected customers on 01/13/2017 to inform them of the issue. Customers with questions were instructed to contact their local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 215,703 units
Distribution Nationwide Distribution
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 = LJS and Original Applicant = ARROW INTL., INC.
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