Reported Jun 23, 2021 · Ongoing
HME for Tracheostomized Patients, Item Code 353S13046 - 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?
- HME for Tracheostomized Patients
- Item Code 353S13046 - 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 Package10884521779372
- GTIN Secondary Package20884521779379
- Lot Numbers19F0869FAX 19F0870FAX 20G1669FAX 20G1670FAX 20H0377FAX
- Amount recalled
- 10890
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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