Device 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.
Z-1866-2021
Product summary
- Firm
- Covidien, LP
- Event
- Event 87925
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32625
- Official record key
device-enforcement:Z-1866-2021
Official wording
Reason: The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.
Code information: GTIN Primary Package: 40884522012981 GTIN Secondary Package: 30884522012984 Lot Numbers: 20G1304FAX 20G1305FAX 20L0026FAX 20L0027FAX 20L0410FAX 20L0411FAX 20L0412FAX
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.
Derived failure modes
-
Unknown
The company was notified by their supplier of sterilization services for airway products in Italy of potential deviations from validated parameters for ethylene oxide sterilization.