FDA Device recall Z-1866-2021
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care pa…
- FDA Device
- Class II
- ongoing
- Published 2021-06-23
On 2021-06-23 the FDA classified a Class II recall of Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care pa… by Covidien, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1866-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-04-29 |
| Published | 2021-06-23 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Covidien |
| Distribution | US |
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.
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.
Identifiers
| code_info | GTIN Primary Package: 40884522012981 GTIN Secondary Package: 30884522012984 Lot Numbers: 20G1304FAX 20G1305FAX 20…GTIN Primary Package: 40884522012981 GTIN Secondary Package: 30884522012984 Lot Numbers: 20G1304FAX 20G1305FAX 20L0026FAX 20L0027FAX 20L0410FAX 20L0411FAX 20L0412FAX |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1866-2021%22
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