FDA-Device2012-07-11Class III
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 sup
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Hazard
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Sold states
Nationwide Distribution including MA
Affected count
4 cases x 10 units per case
Manufactured in
3498 West 2400 South #1050, N/A, Salt Lake City, UT, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1943-2012Don't want to check this manually?
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