—#212520

Product

smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24

FDA product code: LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K994216
Affected lot / code info: UDI/DI 10610586012686, Lot Numbers: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, 6003890.

Why it was recalled

The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.

Root cause (FDA determination)

Process control

Action the firm took

Smiths medical issued an URGENT MEDICAL DEVICE RECALL to its consignees on 02/13/2025 via letter delivered by traceable means. The notice explained the issue, potential risk, and requested the following: Required Actions for Customers 1. Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2. Please return all affected product. 3. Inform all potential users of the product in your organization of this notification and complete and return the attached response form to smithsmedical8171@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product and/or has already been used. 4. If you have distributed the product further, immediately notify your accounts that received the affected product and ask them to contact Sedgwick at 1-888-345-2656 (MF, 8am-5pm ET) to obtain a response form.

Recalling firm

Firm: Smiths Medical ASD, Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

Distribution pattern: Worldwide distribution.

Timeline

Recall initiated: 2025-02-13
Posted by FDA: 2025-03-18
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #212520. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.