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U.S. Department of Health and Human Services

Class 2 Device Recall Pediatric Two Lumen Central Venous Catherization Kit

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  Class 2 Device Recall Pediatric Two Lumen Central Venous Catherization Kit see related information
Date Initiated by Firm May 17, 2019
Create Date October 07, 2019
Recall Status1 Terminated 3 on September 24, 2020
Recall Number Z-0053-2020
Recall Event ID 82984
510(K)Number K900263  
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product Pediatric Two-Lumen Central Venous Catheterization
Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502

Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
Code Information Lot/Batch Numbers: 13F18C0374, 13F18H0580, 13F18D0504, 13F18L0507,  13F18E0380, 13F18L0714, 13F18G0180, 13F18L0936,  13F18G0480
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Customer Service
866-396-2111
Manufacturer Reason
for Recall		 Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
FDA Determined
Cause 2		 Employee error
Action On May 17, 2019, Arrow International issued Urgent Medical Device and Acknowledgement notices to customers via courier service. Customers should take the following actions: 1. Place a copy of the notification with each unit of affected product currently in your inventory. 2. After step (1) is complete, fill out the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to recalls@teleflex.com. Distributors should take the following actions: 1. Place a copy of the notification with each unit of affected product currently in your inventory. 2. Using the provided customer letter template and acknowledgement form, communicate the notification to any of your customers who have received product included within the scope of the notification. 3. Have each of your customers who received the affected product return a completed acknowledgement form to you. 4. Once you have finished collecting and consolidating all of the acknowledgement forms from your customers and placing a copy of the notification with each unit of affected product in your inventory, please completed the enclosed Distributor Acknowledgement Form 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 this field action If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 3,143
Distribution US 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 = FOZ and Original Applicant = ARROW INTL., INC.
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