Smiths Medical Recalls Mislabeled Portex Lumbar Puncture Trays
Smiths Medical ASD Inc. is recalling 100 units of Portex Lumbar Puncture Trays because the inner trays were mislabeled with an incorrect model number.
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, but the source text explicitly states the product was correct and only the labeling was invalid, fitting the rubric for minor labeling errors.
Plain-English summary
Smiths Medical ASD Inc. is recalling 100 units of Portex Lumbar Puncture Trays, Model no. 4826PL-20, Lot #3842192. The recall was initiated because the inner trays were mislabeled with invalid information, specifically labeled as 4824PL-20 instead of the correct 4826PL-20.
The product itself was correct, but the labeling error could cause confusion regarding the specific model number. The affected units were distributed nationwide in the states of Massachusetts, Maryland, Missouri, and Indiana.
Consumers and healthcare facilities should stop using the affected trays and contact Smiths Medical ASD Inc. for further instructions or a return.
The recalled product
- Product
- Portex Lumbar Puncture Tray. Anesthesia Conduction Kit. 4826PL-20 - Product Usage: Portex lumbar puncture trays provide all the materials necessary to measure cerebrospinal fluid pressure and/or collect cerebrospinal fluid specimens. Key components include skin prep materials…
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 100
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)
- Lot #3842192
- Model no. 4826PL-20.
Distribution
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