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 PleuraGuide Kit

  • 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 PleuraGuide Kit see related information
Date Initiated by Firm July 16, 2013
Date Posted August 20, 2013
Recall Status1 Terminated 3 on July 15, 2014
Recall Number Z-1987-2013
Recall Event ID 65678
Product Classification Bottle, collection, vacuum - Product Code KDQ
Product PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200.

Indicated to assist with the insertion of thoracic catheters.
Code Information Part Number: 17100: 10734588, 10734583, 10728237, 10728236, 10728235, 10728234, 10736244, 10736243, 10736242, 10736238, 10734590, 10734589, 10736245, 10852352, 10847222, 10847218, 10842301, 10842299, 10842297, 10840114, 10834292, 10829188, 10852337, 10852334, 10834291, 10834286, 10834284, 10860795, 10857119, 10857111, 10864592, 10864104, 10856867, 10875059, 10875046 , 10871063, 10871059, 10868989, 10879191, 10879190, 10889037, 10887634, 10887292, 10884093, 10879192, 10891329, 10884084;Part Number: 17150: 10728238, 10734584, 10823084, 10800926, 10827874, 10827874, 10834299, 10857110, 10881097, 10874228, 10867130; Part Number 17200: 10728239, 10734585, 10794372, 10802727, 10802725, 10820803, 10825183, 10834338, 10852339, 10864105, 10884087 
Recalling Firm/
Manufacturer		 Atrium Medical Corporation
5 Wentworth Dr
Hudson NH 03051-4929
For Additional Information Contact Timothy J. Talcott
603-880-1433
Manufacturer Reason
for Recall		 Individual component's IFUs are not included with the kit.
FDA Determined
Cause 2		 Labeling Change Control
Action Notice of correction was sent on July 18, 2013 via UPS and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. It provides instructions how to handle the product that may be affected. Additional labeling will be added to the kit to include instructions for use for the additional components. Atrium Medical will confirm through tracking of the UPS letters that each consignee has received the letter of correction. This shall be 100%. Where a UPS delivery cannot be confirmed, Atrium Medical will make good faith effort to contact the consignee to ensure that the letter was received.
Quantity in Commerce 6,516 units
Distribution Nationwide 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.
-
-