Z-2868-2016 Class II Terminated
FDA device recall Z-2868-2016 was initiated by Integra LifeSciences Corp. d.b.a. Integra Pain Management on August 24, 2016 and is designated Class II. Reason for recall: Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer. The recall status is terminated (terminated December 19, 2016). Affected quantity: 320 packages.
Recall Details
- Product Type
- Devices
- Report Date
- September 28, 2016
- Initiation Date
- August 24, 2016
- Termination Date
- December 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 320 packages
Product Description
PHS Spinal Tray 24G Gertie Marx, Catalogue No. 899379. 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 anesthetics.
Reason for Recall
Integra LifeSciences has recently identified that one lot of Spinal Tray 24 G Gertie Marx Catalogue # 899379 was shipped containing the 24 G Gertie Marx needle without an introducer.
Distribution Pattern
Distributed to CA.
Code Information
Lot Number affected: W1503532