Reported Dec 25, 2013 · Terminated
Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder Number 340269 Rx Only Product Usage: The Integra…
Integra LifeSciences Corp. d.b.a. Integra Pain Management
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Integra LifeSciences Corp. d.b.a. Integra Pain Management · 3498 West 2400 South #1050 · Salt Lake City, UT · 84119
Is this the product you have?
- Integra Disposable, Convenience Kit Single Shot Epidural Tray Reorder
- Number 340269 Rx Only Product UsageThe 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
- Lot codes and dates
- Kit Cat No
10-243313-259513-261613-26283104195340306134031503403316340357934037273403776340381334039893404131340426934042933404417340446834045783503559CUS025CUS1121-01CUS1164-02CUS1202-04CUS1298-03CUS1376CUS1376CUS1400-01CUS1406-03CUS1415-04CUS1568-01CUS1664-01CUS1696CUS1723CUS1760CUS1773-01CUS1797CUS279-02CUS416CUS597CUS628-02CUS755PISLL7RSM394RSM395SS1246SS2036-01
- Kit Cat No
- Amount recalled
- 359,250
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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