FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: 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
- Recall number
- Z-1284-2025
- Recalling firm
- Smiths Medical ASD, Inc.
- 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
- Status
- Open, Classified
- Initiated
- 2025-02-13
- Posted
- 2025-03-18
- Terminated
- not on file
- Reason
- The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 1 unit
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- UDI/DI 10610586012723, Lot Numbers: 4235509
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LJT
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28