FDA Device recall Z-1943-2012
Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs an…
- FDA Device
- Class III
- terminated
- Published 2012-07-11
On 2012-07-11 the FDA classified a Class III recall of Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs an… by Integra Lifesciences D B A Integra Pain Management, citing integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1943-2012 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2012-06-07 |
| Published | 2012-07-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences D B A Integra Pain Management |
| Distribution | US |
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 number is 3403644. The intended use of this tray is to provide the surgeon, nurse or other licensed medical professional, a kit of sterile instruments, drugs and other medical materials that will support the administration of anesthesia, be it local, spinal or general administration.
Reason
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Identifiers
| code_info | Lot W1112119 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1943-2012%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.