ConMed Recalls CORE Suction Irrigation Handpiece Y-Tubing Sets
ConMed is recalling CORE Suction Irrigation Handpiece Y-Tubing sets because a crease in the packaging seal 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 3/5 (High).
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 is classified as FDA Class II, and the hazard involves a risk of sterility compromise in a medical device used in surgery, which fits the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
ConMed Corporation is recalling the CORE Suction Irrigation Handpiece Y-Tubing set, Catalog Number CD8200. The product is indicated for use in gynecological and abdominal surgery. The recall covers units with lot codes ranging from 110609X to 20160308X.
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 FDA has classified this as a Class II recall.
The affected 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 further instructions.
The recalled product
- Product
- CORE¿ Suction Irrigation Handpiece Y-Tubing set, with 5mm x 32cm Length Probe for Single Solution or Dual Bags, Catalog Number CD8200 The CORE Suction/Irrigation Y Tubing Set with Trumpet Valves (CD8200) is indicated for use in gynecological and abdominal surgery for
- Manufacturer
- ConMed Corporation
- Hazard
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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