smiths medical ProPort Plastic Venous Access System recall
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
Why was smiths medical ProPort Plastic Venous Access System recalled?
The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI/DI 10610586012532, Lot Numbers: 3968088, 4052396, 4063411, 4101698, 4122782, 4219344, 4232319, 4235596, 4242786, 4317072, 4325879, 4397749, 4420759, 4445594, 4449874.
- 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
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 643 units
- Distribution
- Worldwide distribution.
- Recall date
- March 26, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)