SunTech Medical Recalls Mislabeled Neonate Blood Pressure Cuffs
Suntech Medical is recalling 80 neonate blood pressure cuffs because size #3 cuffs were packaged with size #4 labels.
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 where the wrong size cuff was packaged. No injuries or illnesses are reported in the source text.
Plain-English summary
Suntech Medical, Inc. is recalling 80 disposable neonate blood pressure cuffs. The affected product is the SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, sold in boxes of 20. The recall involves 4 boxes, totaling 80 cuffs, with catalog number 98-0400-98 and lot number A4H201.
The recall is due to a labeling error. The package labels indicate size #4 cuffs, but the actual cuffs inside the packages are size #3. This mislabeling could lead to the use of the incorrect cuff size for patient monitoring.
The affected units were distributed in Pakistan. Consumers and healthcare providers should stop using the affected cuffs and contact Suntech Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
- Manufacturer
- Suntech Medical, Inc.
- 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)
- Catalog # 98-0400-98 Lot Number: A4H201
Distribution
Distribution scope not specified by the agency.
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