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U.S. Department of Health and Human Services

Class 2 Device Recall HydroPICC

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 Class 2 Device Recall HydroPICCsee related information
Date Initiated by FirmAugust 31, 2023
Date PostedOctober 13, 2023
Recall Status1 Open3, Classified
Recall NumberZ-0115-2024
Recall Event ID 93043
510(K)NumberK213550 
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
ProductHydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Code Information UDI-DI: 00850030354068; Lot Number: 11469666
Recalling Firm/
Manufacturer		 Access Vascular, Inc
749 Middlesex Tpke
Billerica MA 01821-3906
For Additional Information ContactBrian Hanley
781-538-6594
Manufacturer Reason
for Recall		Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for adult use only. There is a potential risk to health should the HydroPICC Dual Lumen Catheter be used in an inadequately sized vessel. There have been no reported adverse events to date.
FDA Determined
Cause 2		Error in labeling
ActionAn Urgent Medical Device Correction notification letter dated 8/25/23 was sent to customers. 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. All catheters to date have been used with adult patients. - Product that has not been used: The kit does not have the current IFU. Please refer to the Rev C. IFU provided with this letter. Also, the Patient Information Card, part number LS-067, includes a barcode link to the current revision of the IFU on AVIs website. 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. If you have any questions about this communication, please contact us at 781-538-6594.
Quantity in Commerce58 total
DistributionUS Nationwide distribution in the states of IL, TX.
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 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) Database510(K)s with Product Code = LJS
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