Date Initiated by Firm |
January 03, 2020 |
Create Date |
February 19, 2020 |
Recall Status1 |
Terminated 3 on January 26, 2021 |
Recall Number |
Z-1268-2020 |
Recall Event ID |
84735 |
510(K)Number |
K131855
|
Product Classification |
Colonoscope and accessories, flexible/rigid - Product Code FDF
|
Product |
Pentax Video Colonoscope Model: EC38-i10L |
Code Information |
Serial Numbers:L110746 |
Recalling Firm/ Manufacturer |
Pentax of America Inc 3 Paragon Dr Montvale NJ 07645-1782
|
For Additional Information Contact |
SAME 973-628-2199
|
Manufacturer Reason for Recall |
Distributed in the USA without an approved 510K
|
FDA Determined Cause 2 |
Mixed-up of materials/components |
Action |
Pentax Medical contacted US Affected Customers by telephone to inform them of the pending action and to advise they quarantine the affected products Pentax issued URGENT MEDICAL DEVICE CORRECTIONAND REMOVAL Letter via UPS dated 1/3/20 states: reason for recall, health risk and action to take: Please quarantine the units your facility owns, complete the response form, and return it to PENTAX Medical using the e-mail address or fax number listed below. Upon return of the response form, PENTAX will contact your facility to arrange the return of the affected units. Loaner units will be supplied until this issue is resolved.
Question contact: 1-800-431-5880 (8:30 AM 5:00 PM, Monday Friday, EST) Fax: 201-799-4063 (alternate 201-391-4189) Email: customeradvisories@pentaxmedical.com |
Quantity in Commerce |
1 unit |
Distribution |
NC, MA |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FDF and Original Applicant = PENTAX MEDICAL COMPANY
|