Medical Device Recall: Z-0031-06

FDA Recalls dataset · Firm: Rita Medical Systems · Status: Terminated

Recall Action Class: N/A Date Initiated: 2005-09-21 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0031-06.

Recall Res Number
Z-0031-06
Recalling Firm / Manufacturer
Rita Medical Systems
FEI Number
1000523114
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2005-09-21
Date Posted
2005-10-07
Date Terminated
2006-01-03
Product Code
GEI
Event Number
33623
Product Quantity
N/A
Product Description Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Reason for Recall Devices for which sterility may be compromised as evidenced by a loss of package integrity.
Action Details On 9/21/05, the firm issued letters via UPS to all its direct consignees, informing them of the affected product and providing instructions on the recall.
Distribution Pattern Product was released for distribution to 63 consignees nationwide. The recall was appropriately extended to the consumer/user level; i.e., the physicians and hospitals who received the recalled product. There were no shipments to U.S. Government facilities or foreign or Canadian distribution.
Code Information / Serial Numbers Lot Number: 0011

Related Establishments / Registrations

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Account Required Full available specs will require a free AvaSpecs account.