Recall StatusOpen, Classified
Date Initiated2026-06-15
Product Quantity20
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.
Firm Action
On 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
[email protected]
For additional information on this letter, please email
[email protected]
Distribution Pattern
US: 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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.