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U.S. Department of Health and Human Services

Class 2 Device Recall ARROW PICC powered by ARROW VPS Stylet

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  Class 2 Device Recall ARROW PICC powered by ARROW VPS Stylet see related information
Date Initiated by Firm July 25, 2017
Create Date February 13, 2018
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
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