Recall Z-2868-2016 ยท CAZ Anesthesia Conduction Kit
Integra LifeSciences Corp. d.b.a. Integra Pain Management
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.
| Date | Aug 24, 2016 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Employee error |
| Action | Consignees notified on 8/24/16 via an Urgent - Field Corrective Action letter e-mail. The letter identified the affected device and the reason for the recall. Customers were asked to review their inventory of the Spinal Tray 24 G Gertie Marx to confirm the quantity received. The attached form should be completed and returned by e-mail or fax as indicated. Once the form is received, Customer Service will place an order for the customer to receive replacement devices. Questions should be directed to Customer Service at 1-800-241-2210. |
| Quantity | 320 packages |
| Distribution | Distributed to CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K943319 | GERTIE MARX EPI-SPINAL TRAY Spinal Specialties, Inc., Jun 30, 1995 |