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U.S. Department of Health and Human Services

Class 2 Device Recall HydroPICC 4Fr Single Lumen, 80cm Guidewire

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  Class 2 Device Recall HydroPICC 4Fr Single Lumen, 80cm Guidewire see related information
Date Initiated by Firm December 16, 2022
Date Posted February 10, 2023
Recall Status1 Open3, Classified
Recall Number Z-1130-2023
Recall Event ID 91426
510(K)Number K193015  
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002
Code Information UDI-DI: (01)00862559000463; Lot Number: 11389279, 11391525
Recalling Firm/
Manufacturer
Access Vascular, Inc
749 Middlesex Tpke
Billerica MA 01821-3906
For Additional Information Contact Brian Hanley
781-538-6594
Manufacturer Reason
for Recall
Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.
FDA Determined
Cause 2
Incorrect or no expiration date
Action Urgent Medical Device Correction notification letters were sent to customers beginning 12/16/22.. Access Vascular has identified that the catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package. These catheters are individually packaged and supplied sterile along with a sterile kit. Our records indicate that your facility has received kits from the affected lots. We are contacting you to provide information on action to take to ensure patient safety. - Product that has already been used: No action required. The catheter and all kit components are currently within their expiration date, so no patient safety risk has been identified. - Product that has not been used: The catheter and all kit components are currently, within their expiration date, so no immediate patient safety risk has been identified. However, please refrain from using these kits as using the product used past its expiration date may contaminate the sterile field and result in an infection. AVI will provide a replacement label with the correct expiration date or replace the affected products. The following page identifies the shipments you have received with these impacted lots. 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. Access Vascular is committed to providing the highest quality products and support and is implementing corrective actions to prevent this issue from recurring in the future. We apologize for any inconvenience this may cause you and appreciate your understanding as we take steps to correct this issue. If you have any questions about this communication, please contact us at 781-538-6594.
Distribution US Nationwide distribution in the states of CT, IL, IN, MA, NE, TN, and TX.
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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