Recall Z-1278-2025— Smiths Medical ASD, Inc.
Class I · Ongoing
Class I FDA medical device recall by Smiths Medical ASD, Inc., initiated 2025-02-13. FDA's recall record names no specific 510(k) clearance for this event. Product: smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24. 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
Product description
smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm (8.4Fr) O.D. x 1.0mm I.D., 9 Fr Introducer, REF 21-4151-24
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.