Reported Jun 23, 2021 · Ongoing
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized…
Covidien, LP
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien, LP · 60 Middletown Ave · North Haven, CT · 06473-3908
Is this the product you have?
- Adult-Pediatric Electrostatic Filter HME
- Item Code 352/5877Z - Product Usageindicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm or 22 mm connectors
- Lot codes and dates
- GTIN Primary Package10884521077409
- GTIN Secondary Package20884521077406
- Lot Numbers
20C1164FAX20C1165FAX20C1166FAX20C1235FAX20C1236FAX20D1187FAX20D1188FAX20D1189FAX20D1190FAX20D1191FAX20D1429FAX20D1430FAX20D1432FAX20D1433FAX20D1523FAX20D1524FAX20D1525FAX20D1526FAX20D1527FAX20D1528FAX20E0158FAX20E0159FAX20E0160FAX20E0161FAX20E0162FAX20E0163FAX20E0164FAX20E0165FAX20E0390FAX20E0391FAX20E0392FAX20E0393FAX20E0871FAX20E0873FAX20E0874FAX20E0875FAX20E0935FAX20E0936FAX20E0997FAX20E0998FAX
- Amount recalled
- 192000
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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