Z-1866-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- June 23, 2021
- Initiation Date
- April 29, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32625
Product Description
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.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.
Code Information
GTIN Primary Package: 40884522012981 GTIN Secondary Package: 30884522012984 Lot Numbers: 20G1304FAX 20G1305FAX 20L0026FAX 20L0027FAX 20L0410FAX 20L0411FAX 20L0412FAX