ConMed Linvatec Recalls 24k Arthroscopy Outflow/Suction Tubing Sets
ConMed Linvatec is recalling 24k Arthroscopy Outflow/Suction Tubing Sets because a potential breach in the Tyvek seal could compromise the sterility of the contents.
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 potential breach in the sterile barrier of a medical device used in surgical procedures, which poses a risk of harm without reported injuries.
Plain-English summary
ConMed Linvatec is recalling the 24k Arthroscopy Outflow/Suction Tubing Set (Product Number 24k100). The recall is due to a possibility that the product may have a breach in the Tyvek seal, which could potentially compromise the sterility of the contents.
The affected products were distributed worldwide, including nationwide in the United States and in various international countries. The recall involves 30,064 units across multiple lot numbers.
Healthcare facilities and consumers should stop using the affected tubing sets and contact ConMed Linvatec for further instructions on how to return or dispose of the products.
The recalled product
- Product
- Catheter Irrigation Set labeled in part: ***24K Arthroscopy Outflow/Suction Tubing Set*** This Arthroscopy Tubing Set is intended for use, in conjunction with the ConMed Linvatec 24k Pump, for pump-induced outflow and/or suction of fluid from the joint during arthroscopic…
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Category
- Medical Device — Surgical Tubing
- Hazard
- Affected units
- 30,064
Distribution
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