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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Arterial Catherization Kit

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  Class 2 Device Recall Arrow Arterial Catherization Kit see related information
Date Initiated by Firm December 12, 2019
Create Date January 23, 2020
Recall Status1 Open3, Classified
Recall Number Z-0844-2020
Recall Event ID 84635
510(K)Number K810675  
Product Classification Wire, guide, catheter - Product Code DQX
Product Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide
Product Code: ASK-04020-PMC

The Arrow¿ Arterial Catheterization device permits access to the peripheral arterial circulation or to other small vessels.
Code Information Lot/Batch Number: PMC 23F19H0224
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact SAME
610-378-0131
Manufacturer Reason
for Recall		 The lidstock label incorrectly displays a MR (Magnetic Resonance ) Conditional symbol (instead of a MR Unsafe symbol) in reference to a component of the kit
FDA Determined
Cause 2		 Labeling Change Control
Action Arrow International issued an " Urgent Medical Device Recall Notice" to its US consignee on 12th Dec 2019 via FedEx 2-day mail. The letter states reason for recall, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine the products. 2. Please complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to recalls@teleflex.com. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. If you have no affected stock, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Questions contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 80 eaches
Distribution US distribution to SC
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = ARROW INTL., INC.
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