Smiths Medical Recalls Mislabeled Arterial Blood Sampling Kits
Smiths Medical ASD Inc. is recalling 29,600 Portex Pulsator Arterial Blood Sampling Kits because they were mislabeled with incorrect labels.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The source text identifies the issue as a labeling error without reporting any injuries or illnesses.
Plain-English summary
Smiths Medical ASD Inc. is recalling 29,600 units of the Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2. The affected products are sterile, prescription-only kits manufactured by Smiths Medical ASD Inc. in Keene, NH.
The recall was initiated because the product was mislabeled with the incorrect label. The affected lot numbers are 3306404, 3314069, and 3318698.
The products were distributed nationwide in the states of Connecticut, Massachusetts, Michigan, North Carolina, New Jersey, New York, Rhode Island, Texas, Utah, and Washington. Consumers and healthcare providers should stop using these kits and contact Smiths Medical ASD Inc. for further instructions.
The recalled product
- Product
- Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Blood Sampling
- Hazard
- Affected units
- 29,600
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 (3)
- Lot numbers 3306404
- 3314069
- and 3318698.
Distribution
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