Smiths Medical ProPort Implantable Port Component Separation Due to Manufacturing Defect
Smiths Medical is recalling ProPort Plastic implantable port systems because the plastic port housing and port reservoir may separate due to a manufacturing defect. The recall affects 2,311 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 recall is classified as FDA Class I, which establishes a minimum severity of Severe according to recall classification standards. No deaths or reported injuries are documented in the source.
Plain-English summary
Smiths Medical ASD, Inc. is recalling ProPort Plastic Venous Access System components (PolyFlow Polyurethane Catheter, 1.9mm O.D., REF 21-4152-24) due to a manufacturing defect. The plastic port housing and port reservoir may separate from each other.
The recalled units were distributed worldwide. The defect affects 2,311 units across 41 identified lot numbers. Healthcare facilities and patients with implanted devices should contact their healthcare provider or Smiths Medical for guidance. Additional information is available from the FDA.
The recalled product
- Product
- smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. (5.8 Fr) x 1.0mm I.D., REF 21-4152-24
- Manufacturer
- Smiths Medical ASD, Inc.
- Hazard
- device-separation
- implant-failure
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 10610586012549
- Lot Numbers: 3928188
- 3953708
- 3957301
- 3968097
- 3977434
- 3988450
- 4006475
- 4022600
- 4027912
- 4036893
- 4073108
- 4086999
- 4103105
- 4114110
- 4122783
- 4136362
- 4139518
- 4152689
- 4153871
Distribution
Distribution scope not specified by the agency.
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