Histolock Resection Device, US Endoscopy. An electrosurgical device designed to be used to endoscopically grasp, dissect
FDA device recall Z-0001-2016 · posted 2015-10-01 · Terminated
Recall details
- Recalling firm
- US Endoscopy Group Inc
- Reason for recall
- The company has determined the sterility cannot be assured for the affected lot.
- Action taken
- The firm, US Endoscopy, sent an "URGENT: HISTOLOCK" RESECTION DEVICE RECALL" letter and response form to their customers on July 14, 2015. The letter described the product, problem and action to be taken. The customers were instructed to complete the response form and return to your US Endoscopy Product Specialist and retain a copy of the letter for your records. If you have any questions, contact Sr. Manager, Reg. Affairs & Quality Compliance at 440-358-6251 or email at: ccochara@usendoscopy.com.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- FDI
- Quantity affected
- 41 units
- Distribution
- US Distribution to states of: AL, AR, CA, IL, IN, MS, OH, OK & TN.
- Date initiated
- 2015-07-14
- Date posted
- 2015-10-01
- Date terminated
- 2016-10-27
- Location
- Mentor, OH
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONOFILAMENT POLYPECTOMY SNARE (K140763) | United States Endoscopy | 2014-04-24 |