Gyrus ACMI Falope-Ring Band Applicator Kits Recalled for Sterile Packaging Compromise
Gyrus Acmi is recalling Falope-Ring Band Applicator Kits due to sterile packaging compromises that could lead to bacterial contamination and patient infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (potential bacterial contamination leading to infection) where injury has not yet been reported, aligning with the 'High' severity criteria.
Plain-English summary
Gyrus Acmi, Incorporated is recalling all packages of Gyrus ACMI Disposable Falope-Ring Band Applicator Kits, including REF 006889-901 and REF 005280-901. These sterile, single-use instruments are indicated for female sterilization (permanent contraception) and are designed to occlude both Fallopian tubes. The recall involves 74,792 units distributed worldwide, including the US, Canada, Vietnam, and Europe.
The recall is being conducted due to compromises in the sterile packaging. These packaging issues could be associated with bacterial contamination, which might lead to patient infection. The source text does not report any specific illnesses or injuries associated with this recall.
Healthcare providers and facilities that have received these kits should stop using them and contact the manufacturer for further instructions. Consumers who have had this procedure performed should monitor for signs of infection and contact their healthcare provider if they have concerns.
The recalled product
- Product
- Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the p
- Manufacturer
- Gyrus Acmi, Incorporated
- Affected units
- 74,792
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)
- All lots
Distribution
Distributed nationwide across the United States.
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