Smiths Medical Recalls PORT-A-CATH II Systems Packaged with Incorrect Catheter Size
Smiths Medical is recalling 46 kits of the PORT-A-CATH II POWER P.A.C. Low Profile system because they were packaged with an 8Fr catheter instead of the intended 6Fr catheter.
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 classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The hazard is a packaging error involving the wrong catheter size, which is a significant defect but does not meet the criteria for Severe (Class I) or Critical (death/serious injury).
Plain-English summary
Smiths Medical ASD Inc. is recalling 46 kits of the PORT-A-CATH II POWER P.A.C. Low Profile system (SKU 21-4477-24). The recall was initiated because one lot of the product was packaged with an 8Fr catheter instead of the intended 6Fr catheter.
The affected product is identified by Lot 3921849. The recall covers domestic distribution in Arkansas, Connecticut, Mississippi, Tennessee, and Texas.
Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if it matches the description. Smiths Medical is the recalling firm responsible for this action.
The recalled product
- Product
- PORT-A-CATH¿ II POWER P.A.C. Low Profile" system.
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 46
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 (1)
- Lot 3921849.
Distribution
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