[Recalled] Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for us
Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.
Recall details
| Product | Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical materials that will support the administration of spinal anesthesia for use by a surgeon, nurse or other licensed medical professional. Model nu |
|---|---|
| Brand / manufacturer | Integra LifeSciences Corp. d.b.a. Integra Pain Management |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1943-2012 |
| Country of notice | United States |
| Risk level | Class III |
| Hazard type | recall |
| Notice date | 07 June 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
This Class III 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 Integra LifeSciences Corp. d.b.a. Integra Pain Management
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.
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