Boston Scientific Recalls AMS 700 Reservoirs Due to Labeling Error
Boston Scientific is recalling five AMS 700 100 mL Spherical Reservoirs with InhibiZone because they were incorrectly labeled as a different model.
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 without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Boston Scientific Corporation is recalling five units of the AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156. The recall is due to a labeling discrepancy where the product was incorrectly labeled as the AMS 700 100mL Conceal Low Profile Reservoir with InhibiZone.
The affected devices are intended for use in the treatment of chronic, organic, male erectile dysfunction. The recall covers Lot 24464037. The products were distributed nationwide in the United States, including in the states of California, Maryland, North Carolina, Nevada, and Texas.
Consumers and healthcare providers should stop using the affected devices and contact Boston Scientific Corporation for further instructions.
The recalled product
- Product
- AMS 700 100 mL, Spherical Reservoir with InhibiZone, Part No. 72404156 - Product Usage: intended for use in the treatment of chronic, organic, male erectile dysfunction (impotence).
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 5
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 24464037
Distribution
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