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U.S. Department of Health and Human Services

Class 2 Device Recall Femoral Arterial Line Catheterization Kit

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 Class 2 Device Recall Femoral Arterial Line Catheterization Kitsee related information
Date Initiated by FirmJune 02, 2016
Date PostedJuly 12, 2016
Recall Status1 Terminated 3 on August 21, 2017
Recall NumberZ-2201-2016
Recall Event ID 74489
510(K)NumberK810675 
Product Classification Wire, guide, catheter - Product Code DQX
ProductFemoral Arterial Line Catheterization Kit with Sharps Safety Features 510K 810675, product code DQX, Device Listing D025180 Material ASK-04018-VUH Product Usage: The Arrow arterial catheterization device permits access to the peripheral arterial circulation.
Code Information Lot/Batch Numbers: 23F14M0829, 23F14M0986
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactCustomer Service
855-419-8507
Manufacturer Reason
for Recall
Labeling error. Some shipping cartons labeled as ASK-04018-VUH contained ASK-04020-VUH kits; and some shipping cartons labeled as ASK-04020-VUH contained ASK-04018-VUH kits.
FDA Determined
Cause 2
Labeling mix-ups
ActionArrow International mailed an Urgent Medical Device Recall Notification letter and acknowledgement form dated June 20, 2016 to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to 1. Immediately discontinue distribution and quarantine any products with the product codes and lot numbers listed above. 2. Inspect affected product within your control to identify if the shipping corrugate label correctly identifies the products inside the shipping carton. Products with an incorrect label on the shipping carton can be returned to Arrow. 3. Once you have completed inspection of all of the products from your own inventory, check the box on the enclosed Acknowledgment Form that indicates that you have completed the inspection and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. For questions contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce50 units in total
DistributionUS distribution in the states of TN and KY.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQX
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