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U.S. Department of Health and Human Services

Class 2 Device Recall Catheter, Intravascular

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 Class 2 Device Recall Catheter, Intravascularsee related information
Date Initiated by FirmFebruary 17, 2016
Create DateSeptember 09, 2016
Recall Status1 Terminated 3 on October 18, 2017
Recall NumberZ-2772-2016
Recall Event ID 74898
510(K)NumberK061289 
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
ProductCather, Ultrasound, Intravascular The VPS Stylet and Console are indicated for guidance and tip positioning for central venous catheters.
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 ContactCustomer 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
ActionThe 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 Commerce6,121 units in total
DistributionUS Distribution to states of: NC, OH, FL, and MD.
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 = LJS
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