Recall Z-1282-2025— Smiths Medical ASD, Inc.

Name: FDA recall Z-1282-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-13

Class I · Ongoing

Class I FDA medical device recall by Smiths Medical ASD, Inc., initiated 2025-02-13. It names one FDA 510(k) clearance: K994216. 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. Reason: The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect..

Recalling firm: Smiths Medical ASD, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-02-13
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K994216 — PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEMSims Deltec, Inc.·cleared 2000-01-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.