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
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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
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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.
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Quantity in Commerce | 190 units |
Distribution | US Nationwide distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LJS
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