Z-1943-2012Class III

Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains...

Name: Z-1943-2012 Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains...
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2012-06-07
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2012-06-07 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of Single Shot Epidural Trays, Sterile, Integra Pain Management, West Valley City, Utah 84119, each kit contains sterile instruments, drugs and other medical... on 2012-06-07. FDA classified it as Class III and gives the reason as "Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1943-2012
Classification: Class III
Status: Terminated
Initiated: 2012-06-07
Posted: 2012-07-05
Terminated: 2012-08-07
Recalling firm: Integra Pain Management
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.
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Integra LifeSciences is recalling one lot of Single Shot Epidural Trays as the product was inadvertently shipped missing injectable components.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Integra sent an Urgent - Medical Device Recall letter dated June 7, 2012, to one domestic consignee via Federal Express with a recall acknowledgement form followed up with a telephone call. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete the Recall Acknowledgement Form including quantity of affected product in their inventory. Customers were also instructed to contact Integra Pain Management Customer Service to arrange for returns of all affected product. Product reconciliation will be performed to account for all affected products returned. Returned product will be reprocessed to correct for the missing components. Customers with questions were instructed to call Integra Pain Management Customer Service at 1-800-241-2210. For questions regarding this recall call 609-936-2311.
Quantity in commerce: 4 cases x 10 units per case
Distribution: Nationwide Distribution including MA
Product codes and lots: Lot W1112119

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1943-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1943-2012	Class III	Terminated	Voluntary: Firm initiated	2012-07-11	2012-07-05

Product code CAZ

K945484Class IIPidural Steroid SystemProfessional Medical Device Consultants / cleared 1995-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)