Smiths Medical Recalls Port-A-Cath Needles Due to Incorrect Labeling
Smiths Medical ASD, Inc. is recalling Port-A-Cath Plastic Hub Needles from Lot 46262 because the lid stock labels contain incorrect part numbers, descriptions, and images.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
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 and involves a minor labeling error (incorrect part number and image) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Smiths Medical ASD, Inc. is recalling 130 cartons (1,560 needles) of PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree, Reference 21-2287-24. The recall affects a portion of Lot number 46262. These needles are intended to access the implantable portal system for the infusion or withdrawal of fluids.
The recall was initiated because the label on the lid stock of the individual needle packages contains the incorrect part number, part number description, and product image. The correct part number for this product is 21-2287-24 Port-A-Cath Plastic Hub Bent Needle.
The affected products were distributed worldwide, including nationwide in the United States to California only, as well as to Australia, Belgium, Germany, Hungary, Italy, Sweden, and Switzerland. Users should check their inventory for this specific lot number and part number discrepancy and contact the manufacturer for instructions on how to proceed.
The recalled product
- Product
- PORT-A-CATH Plastic Hub Needles, 0.9mm (20G) x 19mm (3/4 in.) 90-degree. REF 21-2287-24 The Plastic hub PORT-A-CATH (PAC) needles are intended to access the implantable portal system for the purpose of infusion or withdrawal of fluids. These PAC needles can be used with…
- Manufacturer
- Smiths Medical ASD, Inc.
- Category
- Medical Device — Needles
- Hazard
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 46262
Distribution
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