Smiths Medical ProPort Implantable Venous Ports Recalled for Separation Defect
Smiths Medical has recalled 643 ProPort Plastic implantable venous access ports that may separate due to a manufacturing defect. The recall affects units distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification for an implantable medical device with potential for serious patient harm if the port housing separates. No illnesses or injuries have been reported.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the ProPort Plastic Venous Access System (REF 21-4151-24), an implantable port used for accessing the venous system.
The plastic port housing and port reservoir of these devices may separate due to a manufacturing defect. A total of 643 units have been recalled. The affected devices were distributed worldwide and are identified by 15 specific lot numbers: 3968088, 4052396, 4063411, 4101698, 4122782, 4219344, 4232319, 4235596, 4242786, 4317072, 4325879, 4397749, 4420759, 4445594, and 4449874.
Patients and healthcare providers who believe they have received one of these recalled devices should verify the device lot number and contact their healthcare provider for guidance on further management.
The recalled product
- 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
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 643
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (16)
- UDI/DI 10610586012532
- Lot Numbers: 3968088
- 4052396
- 4063411
- 4101698
- 4122782
- 4219344
- 4232319
- 4235596
- 4242786
- 4317072
- 4325879
- 4397749
- 4420759
- 4445594
- 4449874.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 12 recalled by Smiths Medical ASD, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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