Smiths Medical ProPort Plastic Venous Access System Recalled
Smiths Medical is recalling the ProPort Plastic Venous Access System due to a manufacturing defect that may cause the plastic port housing and reservoir to separate.
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: The FDA has classified this as a Class I recall. Class I recalls indicate a serious health hazard. Although no reported illnesses or injuries are mentioned in the source text, the structural defect (separation of port housing and reservoir in an implantable venous access device) represents a significant risk of harm, meeting the Severe threshold.
Plain-English summary
Smiths Medical ASD, Inc. is recalling the ProPort Plastic Implantable Ports (Silicone Catheter, 2.87 O.D., 8.4Fr, 1.0mm I.D., REF 21-4150-24) due to a manufacturing defect. The plastic port housing and port reservoir may separate because of this defect.
The affected product has been distributed worldwide. The recall involves 3 units with UDI/DI 10610586012518 and Lot Number 4235595.
Patients or healthcare providers who have this device should contact Smiths Medical ASD, Inc. for instructions on what steps to take regarding the recalled product.
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.
- Affected units
- 3
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.
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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