Genicon Natura Cannula Recalled for Potential Optical Tip Detachment
Genicon, Inc. is recalling Natura Model 210-105-251 cannulas because the plastic optical tip may detach from the metal shaft.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving structural defects in medical devices that could lead to significant injury.
Plain-English summary
Genicon, Inc. is recalling 17 boxes (85 units) of Natura Model 210-105-251 cannulas, 5mm diameter, 150mm length. The recall involves lots I7931-A and I8069-A.
The recall is being issued because there is a potential for the plastic optical tip to become detached from the metal shaft. This is a Class II recall, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
The affected products were distributed to consignees in Alabama, Delaware, Florida, Georgia, Missouri, North Carolina, and Tennessee, as well as to foreign consignees in Bahrain, Chile, Cyprus, Denmark, Dominican Republic, Egypt, Great Britain, Hong Kong, Ireland, Jordan, Kuwait, Lebanon, Pakistan, Singapore, South Africa, South Korea, and Thailand. Users should stop using the affected cannulas and contact Genicon, Inc. for further instructions.
The recalled product
- Product
- Genicon Natura Model 210-105-251, 5mm diameter, 150mm length (1 cannula) - Product Usage: The universal handle can be used as a pistol grip or like a traditional Trocar handle when using a scope.
- Manufacturer
- Genicon, Inc.
- 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)
- Lots I7931-A and I8069-A
Distribution
Part of a larger recall action
This product is one of 14 recalled by Genicon, Inc. 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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