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U.S. Department of Health and Human Services

Class 2 Device Recall Catheter, Intravascular, Therapeutic, ShortTerm

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  Class 2 Device Recall Catheter, Intravascular, Therapeutic, ShortTerm see related information
Date Initiated by Firm February 17, 2016
Create Date September 09, 2016
Recall Status1 Terminated 3 on October 18, 2017
Recall Number Z-2774-2016
Recall Event ID 74898
510(K)Number K061289  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product Catheter, Intravascular, Therapeutic, Short-Term Less than 30 days

The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access.
Code Information Lot/Batch Numbers:  23F15L0662,23F15J0260,23F15K0983,23F15G0159,23F15J1102,23F15J0259 23F15C1225,23S15G0973,23F15H1033,23F15F0358,23F15K0345,23F15D1514 23F15C1226,23F15H0919,23F15E1091,23F15H0014,23F15D0241,23F15J0533 23F15E1094,23F15H0020,23F15H0740,23F15K1009,23F15J0431,23F15F1836 23F15H0857,23F15K0012,23F15M0313,23F15G0871,23F15J0285
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Customer Service
866-246-6990
Manufacturer Reason
for Recall		 Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.
FDA Determined
Cause 2		 Unknown/Undetermined by firm
Action The firm, Arrow International, sent an "Urgent Medical Device Recall Notification" letter dated 02/19/2016 via FedEx 2-day delivery to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use and quarantine any of the affected products found; return product-a customer service representative will contact you with a RGA number and instructions; and complete and return the enclosed Recall Acknowledgement Form via fax to 1-855-419-8507 Attn: Customer Service or email to recalls@teleflex.com, even if you do not have no affected product. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 6,121 units in total
Distribution US Distribution to states of: NC, OH, FL, and MD.
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 INTERNATIONAL, INC.
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