INTEGRA Spinal Tray 의 리콜

Recall

74867

Class 2

Z-2684-2016

2016-08-04

Terminated

United States

2016-12-19

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148639

Integra lifesciences is recalling spinal trays, cat no. 3404875, because of the affected recalled hospira 5% lidocaine hcl that is a component of some lots of the spinal trays.

Integra sent an Urgent Medical Device letter dated August 4, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to return unused, affected product. Confirmation of the recall notification delivery via delivery verifiable email; Return of Recall Acknowledgement form; Return & disposition of unused, affected product, if the customer in their response indicates they have affected devices. Any products returned to Integra as a result of the recall will be stored in a segregated, labeled area. Recalled products that are returned will be dispositioned as scrap and destroyed. Any Lidocaine returned with the products will be dispositioned as directed in the Hospira Inc. Drug Recall Notification. If you have questions of a customer service nature or beyond the information in the Hospira Inc. URGENT DRUG PRODUCT RECALL NOTICE, please contact either your local Integra Pain Management Sales Representative or customer service at 1-800-241-2210. For further questions, please call (801) 886-9505.