Recall Z-0006-2013— US Endoscopy Group Inc

Name: FDA recall Z-0006-2013
Creator: U.S. Food and Drug Administration
Published: 2011-11-14

Class II · Terminated

Class II FDA medical device recall by US Endoscopy Group Inc, initiated 2011-11-14, terminated 2013-07-02. It names one FDA 510(k) clearance: K962676. Product: Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.. Reason: When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition..

Recalling firm: US Endoscopy Group Inc
Classification: Class II
Status: Terminated
Initiated: 2011-11-14
Terminated: 2013-07-02
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K962676 — DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICEUnited States Endoscopy Group, Inc.·cleared 1996-10-04

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected tissue specimens in endoscopic procedures of the upper and lower gastrointestinal tract or biliary tract.

Reason for recall

When the outer catheter is either coiled or in a contorted configuration outside of the endoscope and the patient, and excessive force is applied to the handle, the jaws may become inoperable and may become stuck in the open condition.

Data sourced from openFDA. This site is unofficial and independent of the FDA.