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U.S. Department of Health and Human Services

Class 2 Device Recall LCath PICC

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 Class 2 Device Recall LCath PICCsee related information
Date Initiated by FirmJune 15, 2026
Date PostedJuly 24, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2803-2026
Recall Event ID 99333
510(K)NumberK230669 
Product Classification Catheter, intravascular, therapeutic, long-term greater than 30 days - Product Code LJS
ProductL-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F) 0.60mm x 30cm, REF: 384539; 18ga (3.5F) 1.15mm x 60cm, REF: 384464; Basic Kit 28GA (1.2F) x 25cm 1 Lumen), REF: 384516; 20ga (3F) 1.00mm x 60cm, REF: 384463
Code Information REF/UDI-DI/Lot(Expiration): 384539/00886333209934/11488167(7/14/2026), 11488168(7/17/2026), 11494535E(8/1/2026), 11507766(11/13/2026), 11550780(12/12/2026), 11551487(12/15/2026), 11551488(12/15/2026); 384464/00886333209835/11490593(7/28/2026), 11494886(8/28/2026)11501150(10/6/2026); 384516/00886333209910/11500410(8/14/2026), 11501856(8/14/2026), 11504222(9/9/2026), 11506952(9/9/2026), 11523868(9/18/2026), 11551789(9/18/2026), 11553909(11/13/2026), 11559226(11/20/2026); 384463/00886333209828/11490797(8/1/2026), 11490959(8/11/2026)
FEI Number 1625425
Recalling Firm/
Manufacturer		 Argon Medical Devices, Inc
1445 Flat Creek Rd
Athens TX 75751-5002
For Additional Information ContactScott Bishop
469-430-0546
Manufacturer Reason
for Recall		Catheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and sampling, may experience leaking and/or cracking at the hub, which may lead to replacement, inability to flush/aspirate catheter, catheter occlusion, therapy interruption, blood loss, tissue irritation, bloodstream infection.
FDA Determined
Cause 2		Device Design
ActionOn 6/15/2026, recall notices were emailed to customers who were asked to do the following: 1) Provide this recall notice to all people who need to be aware within your organization or to any organization where the potentially affected product has been transferred. 2) Segregate, quarantine, and return affected devices to recalling firm. 3) Complete and return the response form via email Arbee.cummings@argonmedical.com For additional information on this letter, please email Scott.Bishop@argonmedical.com
Quantity in Commerce6928
DistributionUS: AR, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, ND, NJ, NV, NY, OR, TN, TX, UT, VA, WA. OUS: MYS, CAN, SAU
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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