BrosMed Hermes NC PTA Balloon Catheter Recalled for Labeling Error
BrosMed Medical Co., Ltd. is recalling 400 Hermes NC PTA Balloon Dilatation Catheters because the labels display incorrect, higher-rated burst pressure information.
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 labeling error regarding burst pressure. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries or illnesses are classified as Moderate.
Plain-English summary
BrosMed Medical Co., Ltd. is recalling 400 units of the Hermes NC PTA Balloon Dilatation Catheter. The recall is due to a labeling error where the product labels display incorrect, higher-rated burst pressure information than the actual device specifications.
The affected devices are intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The devices are also indicated for stent dilatation post-deployment in the peripheral vasculature. The recall covers specific lot numbers: F1800580, F1800582, F1800583, F1800585, F1800581, F1800584, F1804186, F1804187, F1804188, and F1804189.
The affected products were distributed in the United States to Missouri. Healthcare providers and facilities that have received these devices should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous…
- Manufacturer
- BrosMed Medical Co.,Ltd.
- Hazard
- Affected units
- 400
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 (10)
- Lot #'s: F1800580
- F1800582
- F1800583
- F1800585
- F1800581
- F1800584
- F1804186
- F1804187
- F1804188
- and F1804189.
Distribution
Distributed in 1 state:
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