Recall Z-1416-2017— US Endoscopy Group Inc

Name: FDA recall Z-1416-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-13

Class III · Terminated

Class III FDA medical device recall by US Endoscopy Group Inc, initiated 2016-12-13, terminated 2017-06-13. It names one FDA 510(k) clearance: K122462. Product: Roth Net Polyp Retrieval. Reason: The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration..

Recalling firm: US Endoscopy Group Inc
Classification: Class III
Status: Terminated
Initiated: 2016-12-13
Terminated: 2017-06-13
Firm location: Mentor, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K122462 — ROTH NET RETRIEVERUnited States Endoscopy Group, Inc.·cleared 2012-09-11

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

Roth Net Polyp Retrieval

Reason for recall

The firm was notified that the expiration date on the outer carton is different than the expiration date on the inner package. The expiration date is shorter than the actual expiration.

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