Smiths Medical ProPort Implantable Port Housing May Separate Due to Manufacturing Defect
Smiths Medical is recalling 9,506 ProPort implantable venous access ports due to a manufacturing defect that may cause the port housing and reservoir to separate. No injuries have been reported.
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: FDA Class I classification applies, establishing a minimum severity threshold. The manufacturing defect causing separation of an implantable port housing and reservoir represents a structural failure of an implanted medical device. Although no illnesses or injuries have been reported, the defect poses serious potential harm through impaired device function.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 9,506 units of the ProPort Plastic Implantable Venous Access System (model REF 21-4153-24) because the plastic port housing and port reservoir may separate due to a manufacturing defect. This could result in loss of device function.
The affected devices were distributed worldwide. Specific lot numbers are identified in the recall notice. Patients who have received one of these devices should contact their healthcare provider to determine if they are affected and discuss next steps.
No illnesses or injuries have been reported in connection with this defect. The FDA classified this as a Class I recall, indicating the potential for serious adverse health consequences from device failure.
The recalled product
- Product
- smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm (5.8Fr) O.D. x 1.0mm I.D., 6Fr Introducer, REF 21-4153-24
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- device-separation
- implant-failure
- loss-of-function
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 (20)
- UDI/DI 10610586012563
- Lot Numbers: 3926121
- 3928189
- 3953709
- 3957303
- 4006476
- 4008521
- 4036894
- 4046803
- 4096337
- 4108664
- 4114114
- 4114115
- 4136363
- 4146466
- 4153872
- 4173601
- 4232305
- 4235508
- 4235598
Distribution
Distribution scope not specified by the agency.
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