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U.S. Department of Health and Human Services

Class 2 Device Recall HydroMID 4F Single Lumen Midline Catheter

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  Class 2 Device Recall HydroMID 4F Single Lumen Midline Catheter see related information
Date Initiated by Firm December 22, 2022
Date Posted February 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-1156-2023
Recall Event ID 91533
510(K)Number K203069  
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product HydroMID 4Fr Single Lumen Maximal Barrier Kit-indicated for short term access (<30days) to the peripheral venous access system for intravenous therapy
Product Number: 80004004
Code Information UDI-DI: (01)00850030354020 Lot Numbers: 11424032, 11432076
Recalling Firm/
Manufacturer		 Access Vascular, Inc
749 Middlesex Tpke
Billerica MA 01821-3906
For Additional Information Contact SAME
781-538-6594
Manufacturer Reason
for Recall		 Label with the incorrect component listed on the inner kit Tyvek header bag
FDA Determined
Cause 2		 Under Investigation by firm
Action Access Vascular issued Urgent Medical Device Correction-HydroMID¿ Labeling on 12/22/22. Letter states reason for recall, health risk and action to take: Product that has already been used: No action required. There is no patient safety risk has been identified. - Product that has not been used: The kit labeling identified components which are not included in the kit, however there is no immediate patient safety risk. However, please refrain from using these kits as additional kit components may be required may cause an inconvenient in completing the procedure. AVI will provide a replacement label with the correct contents or replace the product. Please forward this notice in the event the affected product was further distributed. We will contact you to identify the number of kits that are currently in your inventory and determine the appropriate correction with your input, in a timely manner. If you have any questions about this communication, please contact us at 781-538-6594.
Quantity in Commerce 445 units
Distribution US Nationwide distribution in the states of CT, FL, NE, TN, TX, WA.
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 = FOZ and Original Applicant = Access Vascular Inc.
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