Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - 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 approximately 7,200 units of Mechanical Filter with Connector Small, Tethered Cap (Item Code 351/5979) used on anesthetized and respiratory care patients. The recall was initiated after the company's sterilization supplier in Italy notified them of potential deviations from validated parameters during ethylene oxide sterilization of the product. The affected lot number is 20J0699FAX, and the product was distributed worldwide, including in the US states of Delaware, Kentucky, New York, Texas, Virginia, Vermont, and Washington.
The source document does not specify a remedy or any actions affected consumers should take regarding this recall.
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: 7200 Lot/code info: GTIN Primary Package: 20884522033234 GTIN Secondary Package: 10884522033237 Lot Number: 20J0699FAX
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.