ConMed CORE Trumpet Handpiece Recalled for Packaging Seal Crease
ConMed is recalling CORE Trumpet Handpieces because a crease in the packaging seal may create an open channel that compromises the product's 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, and the hazard involves a potential compromise of sterility due to a packaging defect. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity score.
Plain-English summary
ConMed Corporation is recalling CORE Trumpet Handpieces with 5mm x 32cm Length Probes, including catalog numbers CD81XX, CD83XX, and CD84XX. The recall covers units with lot codes ranging from 110609X to 20160308X. These medical devices are used in gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
The recall was initiated because the packaging seal may contain a crease. This crease may result in an open channel, which could compromise the sterility of the product. The affected units were distributed nationwide in the United States and internationally to Australia, Austria, Uruguay, Denmark, Germany, Ireland, Italy, the United Kingdom, Guatemala, the Czech Republic, and Canada.
Healthcare providers and facilities should stop using the affected handpieces and contact ConMed Corporation for further instructions on the recall process.
The recalled product
- Product
- CORE¿ Trumpet Handpiece with 5mm x 32cm Length Probe , Catalog Number CD8400 The CORE Trumpet (CD81XX, CD83XX, and CD84XX) has applications in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures
- Manufacturer
- ConMed Corporation
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)
- Beginning Lot Code 110609X to Ending Lot Code 20160308X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by ConMed Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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