Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Rocket KCH Fetal Bladder Drain

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Rocket KCH Fetal Bladder Drain see related information
Date Initiated by Firm August 01, 2019
Create Date November 26, 2019
Recall Status1 Terminated 3 on November 02, 2021
Recall Number Z-0512-2020
Recall Event ID 83587
HDE Number H970001 
Product Classification Stent, bladder, fetal - Product Code MPR
Product Rocket KCH Fetal Bladder Drainage Catheter
Model: R57405
Code Information All lots (UDI): 05055270913678
Recalling Firm/
Manufacturer		 Rocket Medical Plc
Industrial Estate Sedling Road Wear Indu
Tyne & Wear
Washington United Kingdom
Manufacturer Reason
for Recall		 A complaint was received regarding kinking of the device prior to use. If a device is kinked it cannot be used. In addition, the company became aware that the device had been used for pleural drainage, which is not included in the device indications.
FDA Determined
Cause 2		 Labeling design
Action Rocket Medical issued Urgent Field Safety Notice (FSN) dated July 30, 2019 advising of problem, action taken: update to IFU-Do NOT pull the tip of the catheter in an attempt to straighten it as this will induce twisting of the material and cause the catheter to kink. In addition added :This product is contraindicated for pleural drainage. Communicate this FSN to Hospital Supply Departments, Medical Device Safety Officers and those working within fetal medicine within your facility. For any devices that have been transferred to other organization(s), please ensure that details of these devices are returned to Rocket Medical and that a copy of the FSN is provided to the organization(s) to which the device has been transferred. Complete, scan and return response form, or email your responses, as soon as possible but before August 31st to cust-occ110@rocketmedical.com.
Quantity in Commerce 1081
Distribution Nationwide
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.
HDE Database HDEs with Product Code = MPR and Original Applicant = ROCKET MEDICAL PLC
-
-