FDA recall Z-1867-2021

Covidien, LP · Class II · device

Product

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.

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.

Key facts

Status
Ongoing
Initiation date
2021-04-29
Report date
2021-06-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
North Haven, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1867-2021