FDAFDA · Food and drugs·Recall number Z-1868-2021
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - 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.
Published June 23, 2021 · Recall initiated: April 29, 2021
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien, LP
- Distributor
- Worldwide distribution - US Nationwide distribution in the states of DE, KY, NY, TX, VA, VT, and WA. Global Distribution.
- Lot
- GTIN Primary Package: 10884521077409 GTIN Secondary Package: 20884521077406 Lot Numbers: 20C1164FAX 20C1165FAX 20C1166FAX 20C1235FAX 20C1236FAX 20D1187FAX 20D1188FAX 20D1189FAX 20D1190FAX 20D1191FAX 20D1429FAX 20D1430FAX 20D1432FAX 20D1433FAX 20D1523FAX 20D1524FAX 20D1525FAX 20D1526FAX 20D1527FAX 20D1528FAX 20E0158FAX 20E0159FAX 20E0160FAX 20E0161FAX 20E0162FAX 20E0163FAX 20E0164FAX 20E0165FAX 20E0390FAX 20E0391FAX 20E0392FAX 20E0393FAX 20E0871FAX 20E0873FAX 20E0874FAX 20E0875FAX 20E0935FAX 20E0936FAX 20E0997FAX 20E0998FAX
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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