Gyrus Medical Recalls Disposable Falope-Ring Band Applicator Kits
Gyrus Medical is recalling 856 units of Disposable Falope-Ring Band Applicator Kits due to a packaging anomaly that may compromise sterility.
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. The hazard is a potential breach of the sterile barrier due to a packaging defect, which is a low-risk contamination issue without reported injuries or illnesses in the source text.
Plain-English summary
Gyrus Medical, Inc. is recalling 856 units of Disposable Falope-Ring Band Applicator Kits (REF 006889-901 and REF 005280-901) distributed in the United States. The affected lots are MK761655, MK764022, MK767655, and MK526401. These sterile, single-use instruments are indicated for female sterilization (permanent contraception).
The recall is due to an anomaly in the packaging process for specific lots. This defect may result in a defective seal that allows a breach of the package's sterile barrier, potentially compromising the sterility of the product. The source notes that such a breach may or may not be easily seen.
Healthcare providers and facilities should stop using the affected kits and contact Gyrus Medical for instructions on return or disposal. The FDA has classified this as a Class II recall.
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…
- Manufacturer
- Gyrus Medical, Inc
- Affected units
- 856
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 (4)
- Lots: MK761655
- MK764022
- MK767655
- MK526401
Distribution
Distribution scope not specified by the agency.
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Similar recalls
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