Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826
FDA Recall Z-0031-06 · Posted 2005-10-07
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Recalling FirmRita Medical Systems
Recall StatusTerminated
Product CodeGEI
Date Initiated2005-09-21
Date Terminated2006-01-03
Reason for Recall
Devices for which sterility may be compromised as evidenced by a loss of package integrity.
Firm 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.
Root Cause
Other
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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