[Recalled] EPIDURAL CATHETERIZATION KIT, Product Code UR-05501 — There is the potential for various failures with the LOR (loss of resistance) s… | FDA 2020-01-15
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | EPIDURAL CATHETERIZATION KIT, Product Code UR-05501 |
|---|---|
| Brand / manufacturer | Arrow International Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1214-2020 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 15 January 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.
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 Arrow International Inc
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.