Class 2 Device Recall ARROW PICC powered by ARROW VPS Stylet

• Date Initiated by Firm: July 25, 2017
• Create Date: February 13, 2018
• Recall Status: Terminated on August 29, 2018
• Recall Number: Z-0601-2018
• Recall Event ID: 78964
• 510(K)Number: K121941
• Product Classification: Peripherally Inserted Central Catheter - Product Code LJS
• Product: ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
• Code Information: Lot/Batch Numbers: 23F17A0038, 23F17A0040, 23F16M0059.
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: 610-378-0131
• Manufacturer Reason for Recall: Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.
• FDA Determined Cause: Packaging process control
• Action: Arrow International notified all U.S. consignees with letter sent on July 25, 2017, via FedEx 2-day. second notification August 22, 2017, third notification November 28, 2017.
• Quantity in Commerce: 2691 total
• 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 = LJS