[Recalled] 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 connec
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | 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. |
|---|---|
| Brand / manufacturer | Covidien, LP |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1868-2021 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 29 April 2021 |
| EAN / barcode | 10884521077409 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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 Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Covidien, LP
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.