Endoscopic retrieval device. The disposable Raptor grasping device in intended to retrieve foreign bodies or resected ti
FDA device recall Z-0006-2013 · posted 2012-10-03 · Terminated
Recall details
- Recalling firm
- US Endoscopy Group Inc
- 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.
- Action taken
- US Endoscopy initiated a Voluntary Product Recall letter initiated November 11, 2011. The letter identified the product the problem and the action needed to be taken by the customer. US Endoscopy will provide a free replacement or grant your facility a credit toward a future purchase for every device that is returned to US Endoscopy or verified as having been used or destroyed. For further questions please call 440-639-4494 ext. 378.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FGO
- Quantity affected
- 1153
- Distribution
- Worldwide Distribution -- USA (nationwide) including the states of AL, AR, AZ, CA, FL, GA, HI, IA, IL, KY, LA, MD, ME, MI, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, W
- Date initiated
- 2011-11-14
- Date posted
- 2012-10-03
- Date terminated
- 2013-07-02
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE ENDOSCOPIC RETRIEVAL DEVICE (K962676) | United States Endoscopy Group, Inc. | 1996-10-04 |