FDA Device recall Z-0533-2014
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a…
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra kits which contain a… by Integra Lifesciences D B A Integra Pain Management, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0533-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-28 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Integra Lifesciences D B A Integra Pain Management |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Kit Cat No: 10-2433,13-2595,13-2616,13-2628,3104195,3403061,3403150,3403316,3403579,3403727,3403776,3403813,3403989,340…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, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0533-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.