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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm December 20, 2019
Create Date February 14, 2020
Recall Status1 Terminated 3 on February 25, 2021
Recall Number Z-1243-2020
Recall Event ID 84688
510(K)Number K820009  
Product Classification Catheter, percutaneous - Product Code DQY
Product Arrow Central Venous Catheterization Kit
ASK-04200-UPM
Code Information Lot Number:  13F18H0209 
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		 Product lidstock contains the incorrect expiration date for the product
FDA Determined
Cause 2		 Incorrect or no expiration date
Action Arrow issued Urgent Medical Device Notification dated 12/20/19 stating reason for recall, health risk and action take: 2. Using the provided customer letter and Recall Acknowledgement Form templates, communicate this recall to any of your customers who have received product included within the scope of the recall. 3. Have the customers return any affected product to you, together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex. If an alternative approach is needed, contact Teleflex Customer Service for more information at 1-866-396-2111. 4. To return affected products from your inventory, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of product to Teleflex. 5. Once you have completed returning all the recalled products from your own inventory and collecting and consolidating all the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and fax it to 1-855-419-8507, Attn: Customer Service, or email it to recalls@teleflex.com. This will allow us to document completion of the recall. 6. If you and your customers have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Foreign consignees,are notified through the international office.
Quantity in Commerce 140
Distribution Nationwide Foreign: AT, AU, DE, CA, CZ, GT, NZ, PL, SK, and ZA
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 = DQY and Original Applicant = ARROW INTL., INC.
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