Medline recalls CONMED AirSeal Access Port kits due to pressure alerts
Medline Industries is recalling 3,551 convenience kits containing CONMED AirSeal Access Ports because they may produce erroneous overpressure alerts and system venting.
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 source identifies a potential for erroneous overpressure alerts and system venting that may delay or end procedures, but does not report any illnesses, injuries, or deaths.
Plain-English summary
Medline Industries, LP is recalling 3,551 convenience kits that contain CONMED AirSeal Access Ports. The affected products include the ADVANCE LAPAROSCOPIC kit (DYNJ911135A) and the CHN GYN ONCOLOGY kit (DYNJ906731M). The recall was initiated by the manufacturer due to a potential for erroneous overpressure alerts and system venting during use.
The affected kits were distributed nationwide in Arizona, California, Indiana, Maryland, Missouri, New Jersey, Ohio, and Wisconsin. Specific lot numbers for the ADVANCE LAPAROSCOPIC kit include 26EDA606. Specific lot numbers for the CHN GYN ONCOLOGY kit include 25KDA658, 25KDB571, 25LDB411, and 26CDA536.
The FDA classifies this as a Class II recall. The source text does not report any illnesses, injuries, or deaths associated with the use of these devices. The potential hazard is that the erroneous alerts and venting may result in delays or the ending of medical procedures.
The recalled product
- Product
- Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731M
- Manufacturer
- Medline Industries, LP
- Affected units
- 3,551
Distribution
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