Smiths Medical ProPort venous access port may separate due to defect
Smiths Medical is recalling ProPort Plastic Venous Access Ports. The plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 3 units distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the rubric, FDA Class I recalls are never scored below 4 due to the reasonable probability of serious adverse health consequences. An implantable venous access port that separates could result in loss of device function and serious clinical complications.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the ProPort Plastic Venous Access System with Silicone Catheter (REF 21-4150-24). This device is an implantable venous access port.
The plastic port housing and port reservoir of the device may separate due to a manufacturing defect. If separation occurs, the device may no longer function properly for its intended purpose.
This recall affects 3 units with lot number 4235595 (UDI/DI 10610586012518) that were distributed worldwide. Patients with this specific device implanted are potentially affected.
Patients and healthcare providers should contact Smiths Medical ASD, Inc. for additional information and instructions. No illnesses or injuries have been reported in connection with this defect.
The recalled product
- Product
- smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. (8.4Fr) s 1.0mm I.D., REF 21-4150-24
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- component-separation
- manufacturing-defect
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 (2)
- UDI/DI 10610586012518
- Lot Number 4235595
Distribution
Distribution scope not specified by the agency.
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