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U.S. Department of Health and Human Services

Class 2 Device Recall ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC).

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 Class 2 Device Recall ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC).see related information
Date Initiated by FirmJuly 25, 2017
Create DateFebruary 13, 2018
Recall Status1 Terminated 3 on August 29, 2018
Recall NumberZ-0602-2018
Recall Event ID 78964
510(K)NumberK113277 
Product Classification Peripherally Inserted Central Catheter - Product Code LJS
ProductArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
Code Information Lot/Batch Numbers: 13F16A0089, 13F16A0180, 13F17B0290, 23F16F0614.
FEI Number 3015859709
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
ActionArrow 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 Commerce2691 total
DistributionUS nationwide distribution.
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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