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U.S. Department of Health and Human Services

Class 2 Device Recall RICHARD WOLF TUBE SET FOR TEM

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  Class 2 Device Recall RICHARD WOLF TUBE SET FOR TEM see related information
Date Initiated by Firm March 11, 2018
Create Date May 14, 2018
Recall Status1 Terminated 3 on March 09, 2022
Recall Number Z-1868-2018
Recall Event ID 79886
510(K)Number K000180  
Product Classification Insufflator, laparoscopic - Product Code HIF
Product RICHARD WOLF TUBE SET FOR TEM, REF 4170.801.

Used for the transanal endoscopic microsurgery.
Code Information Lot numbers: 32062417, 32133317
Recalling Firm/
Manufacturer
Richard Wolf GmbH
Pforzheimer Str. 32
Knittlingen Germany
Manufacturer Reason
for Recall
Tube ends may be mixed up.
FDA Determined
Cause 2
Use error
Action The firm initiated the recall via an Urgent Safety Information letter on 03/11/2018. The letter identified the affected product and the problem involved. Customers were asked to check the inventory for the affected lot numbers and complete the attached answer form. The firm requested that the recalled product be discarded. All users should be notified of the safety information. The completed answer form should be returned via fax to 07043 354467 or e-mail to marek.rast@richard-wolf.com.
Quantity in Commerce 1710 units
Distribution Worldwide Distribution
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 = HIF and Original Applicant = RICHARD WOLF MEDICAL INSTRUMENTS CORP.
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