ConMed Recalls CORE Suction Irrigation Handpieces Due to Packaging Seal Creases
ConMed is recalling CORE Suction Irrigation Handpieces because creases in the packaging seal may create open channels that compromise 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 without reported illnesses or injuries, fitting the criteria for a moderate severity score.
Plain-English summary
ConMed Corporation is recalling the CORE Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185. The recall also covers the CORE Trumpet (CD81XX, CD83XX, and CD84XX), which are used in gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
The recall was initiated because the packaging seal may contain a crease. These creases may result in an open channel, which could compromise the sterility of the product. The affected lot codes range from 110609X to 20160308X.
The products 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. Users should stop using the affected products and contact ConMed Corporation for instructions on return or replacement.
The recalled product
- Product
- CORE¿ Suction Irrigation Handpiece with 5mm x 32cm Length Probe for Single Solution Bags, Catalog Number CD8185 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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