Z-1943-2012 Class III Terminated
FDA device recall Z-1943-2012 was initiated by Integra LifeSciences Corp. d.b.a. Integra Pain Management on June 7, 2012 and is designated Class III. Reason for recall: Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components. The recall status is terminated (terminated August 7, 2012). Affected quantity: 4 cases x 10 units per case.
Recall Details
- Product Type
- Devices
- Report Date
- July 11, 2012
- Initiation Date
- June 7, 2012
- Termination Date
- August 7, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 cases x 10 units per case
Product Description
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 for Recall
Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Distribution Pattern
Nationwide Distribution including MA
Code Information
Lot W1112119