FDA announces Class I recall on defective ports used for vein access
The U.S. Food and Drug Administration (FDA) has announced an urgent recall on behalf of Smiths Medical for its line of ProPort Plastic Implantable Ports, due to a manufacturing defect. The devices are part of a catheter system used to access veins for infusions or for taking blood samples.
Pieces of the ports can separate before, during or after implantation. There have been two reported injuries associated with them, and because of the serious risk of medication leaks or air entering the bloodstream, the recall has been designated a Class I, the FDA’s most serious type.
All known customers were notified about the recall Feb. 13 through an affected Urgent Medical Device Recall letter sent by Smiths Medical. However, defective products could remain in hospital supplies.
What is being recalled?
ProPort kits and trays, both 1.9 mm and 2.6 mm, from these specific lines are subject to the notice:
Item Numbers: 21-4153-24, 21-4155-24, 21-4165-24, 21-4171-24, 21-4183-24, and 21-4187-24.
UDIs: 10610586012563, 10610586012594, 10610586012686, 10610586012716, 10610586012778, and 10610586012839.
Check the FDA notice for more details, including lot numbers.
Next Steps
Do not use any of the plastic ports from affected lots. If they’ve already been implanted in a patient, monitor them closely. The FDA said symptoms such as swelling, redness, or discomfort at the implant site may indicate leakage or system failure.
All unused products should be quarantined immediately. All products in distribution centers must be removed from supply.
Any customer in possession of the defective ports should contact Smiths Medical to initiate a refund or replacement. To do so, email [email protected] or call 1-888-345-2656 to obtain a response form.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.