Smiths Medical Recalls PORT-A-CATH Introducer Sets Due to Sizing Issues
Smiths Medical is voluntarily recalling PORT-A-CATH Introducer Sets because the sheath opening may be too small for the catheter width.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is a voluntary precautionary action for a sizing defect with no reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Smiths Medical is conducting a voluntary recall of PORT-A-CATH and PORT-A-CATH II Implantable Venous and Arterial Access Systems and Introducer Sets. The recall involves 190 units of the 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, REF 21-2386-24.
The recall was initiated after Smiths Medical received a small number of customer reports indicating that the introducer sheath and the introducer opening were too small for the width of the catheter when using these sets. The products are designed to permit repeated access to the vascular system for the parenteral delivery of medications, fluids, and nutritional solutions, and for the sampling of venous blood.
The affected products were distributed worldwide, including in the United States and internationally to Denmark, Belgium, and Canada. Smiths Medical has received no reports of injuries or illnesses associated with this issue. Healthcare providers and consumers should stop using the affected introducer sets and contact Smiths Medical for further instructions.
The recalled product
- Product
- Smith Medical, Deltec, REF 21-2386-24, 11 Fr Introducer Set with Peel-Away Sheath, Sterile EO, Rx Only PORT-A-CATH¿ and PORT-A-CATH¿ II implantable venous and arterial access systems are designed to permit repeated access to the vascular system for the parenteral delivery of
- Manufacturer
- Smiths Medical ASD, Inc.
- Affected units
- 190
Distribution
Part of a larger recall action
This product is one of 2 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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