Z-0031-06

Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA...

Name: Z-0031-06 Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA...
Creator: Rita Medical Systems
Published: 2005-09-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2005-09-21 / Terminated / root cause: packaging

FDA source

Rita Medical Systems began a recall of Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA... on 2005-09-21. The reason FDA records is "Devices for which sterility may be compromised as evidenced by a loss of package integrity". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0031-06
Status: Terminated
Initiated: 2005-09-21
Posted: 2005-10-07
Terminated: 2006-01-03
Recalling firm: Boston Scientific Corporation
Product: Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
Product code: GEI Electrosurgical, Cutting & Coagulation & Accessories
Reason for recall: Devices for which sterility may be compromised as evidenced by a loss of package integrity.
Root cause tag: packaging
FDA root cause: Other
Action: 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: 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.
Product codes and lots: Lot Number: 0011

Product code GEI

K051420Class IIHabib 4XEmcision , Ltd. / cleared 2005-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)