Date Initiated by Firm | August 04, 2016 |
Create Date | August 29, 2016 |
Recall Status1 |
Terminated 3 on December 19, 2016 |
Recall Number | Z-2684-2016 |
Recall Event ID |
74867 |
510(K)Number | K943319 |
Product Classification |
Anesthesia conduction kit - Product Code CAZ
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Product | INTEGRA Spinal Tray, Catalogue No: 3404875, Contents: 10 Each per Case, Sterile. |
Code Information |
The affected lots of Integra¿ Spinal Trays were manufactured on 2/11/205 and on 7/11/2015. Lots: W1503004; S1501531; S1505556; |
Recalling Firm/ Manufacturer |
Integra LifeSciences Corp. d.b.a. Integra Pain Management 3498 W 2400 S Ste 1050 Salt Lake City UT 84119-1135
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For Additional Information Contact | Dr. Patricia W. Kihn 801-886-9505 |
Manufacturer Reason for Recall | 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. |
FDA Determined Cause 2 | Other |
Action | 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. |
Quantity in Commerce | 200 packages (20 cases) |
Distribution | US Distribution to the states of : OH and CA. No foreign, Govt/VA/military consignee. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CAZ
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