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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow ErgoPack

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  Class 2 Device Recall Arrow ErgoPack see related information
Date Initiated by Firm August 10, 2023
Date Posted September 15, 2023
Recall Status1 Open3, Classified
Recall Number Z-2590-2023
Recall Event ID 92850
510(K)Number K073451  
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
Product Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Code Information Batch/Lot number 13F22J0617
Recalling Firm/
Manufacturer		 ARROW INTERNATIONAL Inc.
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer Reason
for Recall		 This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
FDA Determined
Cause 2		 Under Investigation by firm
Action Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions: Medical facilities: Immediately cease use and distribution of affected product and quarantine for return. Distributors: Immediately cease use and distribution of affected product and quarantine for return. Provide a copy of this recall notice to all customers who have received impacted product. Request they complete the Acknowledgement Form and return it to you. Firm is requesting return of the affected product.
Quantity in Commerce 190 units
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = LJS and Original Applicant = ARROW INTERNATIONAL, INC.
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