Smiths Medical ProPort Plastic Venous Access System recalled for port separation defect
Smiths Medical is recalling its ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate, affecting 1,695 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: FDA Class I classification mandates a minimum severity score of 4. While no deaths or illnesses have been reported, the manufacturing defect affecting a critical implanted venous access device presents a reasonable possibility of serious adverse health consequences.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the ProPort Plastic Venous Access System (REF 21-4165-24), a pre-assembled plastic implantable venous access system with a PolyFlow Polyurethane Catheter (2.6mm O.D. x 1.6mm I.D.) and 8.6Fr Introducer.
A manufacturing defect may cause the plastic port housing and port reservoir to separate. The recall affects 1,695 units distributed worldwide.
The affected lot numbers are: 3918902, 3984420, 4079312, 4189868, 4221726, 4235543, 4242787, 4294897, 4307477, 4356314, 4364692, 4390226, 4445595, 4468593, and 6003890.
The recalled product
- Product
- smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm (7.8Fr) O.D. x 1.6mm I.D., 8.6Fr Introducer, REF 21-4165-24
- 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 (16)
- UDI/DI 10610586012686
- Lot Numbers: 3918902
- 3984420
- 4079312
- 4189868
- 4221726
- 4235543
- 4242787
- 4294897
- 4307477
- 4356314
- 4364692
- 4390226
- 4445595
- 4468593
- 6003890.
Distribution
Distribution scope not specified by the agency.
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