Food, drugs, devices › Integra LifeSciences Corp. d.b.a. Integra Pain Management
Device recall: Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile in
Integra LifeSciences Corp. d.b.a. Integra Pain Management (Salt Lake City, UT) initiated this device recall on 7 Jun 2012; FDA lists 1 product record under event 61525, classified Class III.
FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 6% of the 823 device enforcement events initiated in 2012 carry the same class.
Status: Terminated, terminated 7 Aug 2012. Initiation: voluntary: firm initiated. Integra LifeSciences Corp. d.b.a. Integra Pain Management has 10 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Integra LifeSciences Corp. d.b.a. Integra Pain Management, Salt Lake City, UT.
Reason for recall
"Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components."
Distribution
"Nationwide Distribution including MA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1943-2012 | 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.… | 4 cases x 10 units per case | Class III | Terminated | 11 Jul 2012 |
Context
Other enforcement events for Integra LifeSciences Corp. d.b.a. Integra Pain Management
All 10 events for Integra LifeSciences Corp. d.b.a. Integra Pain Management
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components."
What does Class III mean?
FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide Distribution including MA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 7 Aug 2012. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.