Gyrus ACMI Falope-Ring Dilator Recalled for Non-Sterile Stand-Alone Sales
Gyrus Medical is recalling 507 units of the ACMI Falope-Ring Dilator because the non-sterile component was sold as a stand-alone item.
What this means for you
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. The hazard involves a non-sterile component being sold as a stand-alone item, which presents a theoretical risk of infection or improper use, but the source text does not report any specific illnesses, injuries, or hospitalizations.
Plain-English summary
Gyrus Medical, Inc. is recalling 507 units of the Gyrus ACMI Falope-Ring Dilator (item 000878-4). This conical plastic device is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30) and is intended to assist in the placement of the Falope-Ring band on a reusable applicator.
The recall is being conducted because the dilator, which is a non-sterile component, has been sold as a stand-alone item. The device is catalog number 000878-4 and is not lot controlled.
The affected units were distributed worldwide, including nationwide distribution in the United States across multiple states and in Canada. Consumers and healthcare providers should stop using the recalled dilator and contact Gyrus Medical for further instructions.
The recalled product
- Product
- Gyrus ACMI Falope-Ring Dilator, item 000878-4. The Falope-Ring Dilator is a conical plastic device that is a component of the Falope-Ring Band Contraceptive Tubal Occlusion Device procedure pack (FRB-30). The Falope-Ring Band Contraceptive Tubal Occlusion Device (TOD) consists
- Manufacturer
- Gyrus Medical, Inc
- Affected units
- 507
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)
- catalog No.: 000878-4
- not lot controlled.
Distribution
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