Electrostatic Filter Angled recalled for sterilization validation deviations
Covidien LP is recalling Electrostatic Filter Angled devices (Item 350S19006) due to potential deviations in ethylene oxide sterilization parameters. These respiratory airway devices for anesthetized patients may not meet required sterility standards.
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: FDA Class II medical device recall with a sterilization defect in a risk-of-harm product (respiratory airway devices for anesthetized patients). No illnesses or injuries are reported in the source text, and the hazard is described as potential rather than confirmed.
Plain-English summary
Covidien LP is recalling approximately 32,625 units of the Electrostatic Filter Angled (Item Code 350S19006), an airway device indicated for single use on anesthetized patients and respiratory care patients requiring breathing circuits with ISO standard 15mm or 22mm connectors.
The company was notified by its ethylene oxide sterilization service supplier in Italy of potential deviations from validated sterilization parameters. These deviations may affect the sterility of the affected devices.
The recalled units have worldwide distribution, with US distribution in Delaware, Kentucky, New York, Texas, Virginia, Vermont, and Washington. Affected lot numbers are: 20G1304FAX, 20G1305FAX, 20L0026FAX, 20L0027FAX, 20L0410FAX, 20L0411FAX, and 20L0412FAX.
Healthcare providers and patients with devices bearing these lot numbers should contact Covidien LP for guidance regarding the proper handling and disposal of the recalled products.
The recalled product
- Product
- Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors.
- Manufacturer
- Covidien, LP
- Affected units
- 32,625
Distribution
Part of a larger recall action
This product is one of 4 recalled by Covidien, LP 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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