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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 FirmFebruary 24, 2021
Date PostedNovember 08, 2022
Recall Status1 Terminated 3 on May 30, 2024
Recall NumberZ-0199-2023
Recall Event ID 90981
510(K)NumberK193015 
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
ProductScalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Code Information UDI-DI: 00862559000418 Catheter Kit Lots/Expiration Dates 09112001 Exp 9/24/2021 10212001 Exp 10/21/21 10282001 Exp 11/18/21 Scalpel Lots/Expiration Dates R18-08-010 Exp Feb-21 R19-01-009 Exp Jun-21 R20-01-010 Exp Aug-22 StatLock Lots/Expiration Dates R18-09-008 Exp 5/28/2021
Recalling Firm/
Manufacturer		 Access Vascular, Inc.
749 Middlesex Tpke
Billerica MA 01821-3906
For Additional Information ContactBrian Hanley
781-538-6594 Ext. 101
Manufacturer Reason
for Recall		Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.
FDA Determined
Cause 2		Process design
ActionBeginning February 24, 2021, the firm notified its affected consignees via Email. Customers were informed that if product had already been used, then no action was required, because all components were still within their expiration date at the time, and no patient safety risk was identified. If product had not been used, customers were asked to refrain from using product until a replacement Scalpel and Statlock were provided.
Quantity in Commerce79 kits
DistributionDomestic distribution to NC, RI, NJ, and IL. No foreign distribution.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LJS
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