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Integra LifeSciences Corp. d.b.a. Integra Pain Management recalls Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Int
Recalled December 25, 2013 · FDA recall Z-0533-2014 · Integra LifeSciences Corp.
Hazard
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. · FDA Class II
Units
359,250
Sold at
USA Nationwide Distribution and one foreign consignee in Mursalat.
Description
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.
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.
Manufacturer(s)
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →