Recall Z-1284-2025— 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, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24. 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, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm O.D. (7.8Fr) x 1.6mm I.D., REF 21-4172-24
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.