Z-0533-2014Class II

Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only

Name: Z-0533-2014 Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only
Creator: Integra LifeSciences Corp. d.b.a. Integra Pain Management
Published: 2013-10-28
License: https://open.fda.gov/license/

Integra Pain Management / initiated 2013-10-28 / Terminated / root cause: design

FDA source

Integra LifeSciences Corp. d.b.a. Integra Pain Management began a recall of Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are... on 2013-10-28. FDA classified it as Class II and gives the reason as "Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0533-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-28
Posted: 2013-12-17
Terminated: 2014-01-29
Recalling firm: Integra Pain Management
Product: Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a BD LOR syringe are intended to provide licensed medical professionals with a kit containing drugs and other medical devices that are used to support the administration of general, local or spinal anesthetics. The BD LOR syringe is intended for use, in conjunction with an epidural needle, to verify the needle tip placement is in the epidural space by use of the Loss of Resistance Technique as detailed in medical textbooks and medical journal articles. The LOR Syringe is not intended for injection or aspiration.
Product code: CAZ Anesthesia Conduction Kit
Reason for recall: Integra LifeSciences Corporation is recalling certain lots of Integra Kits for Epidural Anesthesia Administration as a result of a Product Advisory Notice from BD Medical for the LOR syringes indicating the plunger of the syringe may stall or stick when travelling within the syringe.
Root cause tag: design
FDA root cause: Component design/selection
Action: BD Medical sent a Product Advisory Notice letter dated August 23, 2013 to Iaffected consignees by via traceable courier. The letter identified the affected product, problem and actions to be taken. Distributor have been asked to forward copies of the notification to their customers. For questions call BD Customer Service at 1-888-237-2762.
Quantity in commerce: 359,250
Distribution: USA Nationwide Distribution and one foreign consignee in Mursalat.
Product codes and lots: Kit Cat No: 10-2433,13-2595,13-2616,13-2628,3104195,3403061,3403150,3403316,3403579,3403727,3403776,3403813,3403989,3404131,3404269,3404293,3404417,3404468,3404578,3503559,CUS025,CUS1121-01,CUS1164-02,CUS1202-04,CUS1298-03,CUS1376,CUS1376,CUS1400-01,CUS1406-03,CUS1415-04,CUS1568-01,CUS1664-01,CUS1696,CUS1723,CUS1760,CUS1773-01,CUS1797,CUS279-02,CUS416,CUS597,CUS628-02,CUS755,PISLL7,RSM394,RSM395,SS1246,SS2036-01,

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0533-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0533-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-17

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)