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.
Check against the official notice below — it lists the full affected range.
Covidien, LP is recalling its Electrostatic Filter Angled (Item Code 350S19006), a single-use breathing circuit filter for anesthetized and respiratory care patients. The recall was initiated after the company's sterilization supplier in Italy reported potential deviations from validated ethylene oxide sterilization parameters. A total of 32,625 units were distributed worldwide and across seven U.S. states (Delaware, Kentucky, New York, Texas, Virginia, Vermont, and Washington).
The affected products can be identified by the lot numbers 20G1304FAX, 20G1305FAX, 20L0026FAX, 20L0027FAX, 20L0410FAX, 20L0411FAX, and 20L0412FAX, with the primary package GTIN 40884522012981 and secondary package GTIN 30884522012984. The source document does not specify what actions an affected consumer should take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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: Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution. Quantity: 32625 Lot/code info: GTIN Primary Package: 40884522012981 GTIN Secondary Package: 30884522012984 Lot Numbers: 20G1304FAX 20G1305FAX 20L0026FAX 20L0027FAX 20L0410FAX 20L0411FAX 20L0412FAX
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.