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 TruChoice and 3T Medical Systems Adjustable Vent Valve

  • 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 TruChoice and 3T Medical Systems Adjustable Vent Valve see related information
Date Initiated by Firm July 21, 2011
Date Posted August 23, 2011
Recall Status1 Terminated 3 on April 23, 2012
Recall Number Z-3060-2011
Recall Event ID 59524
510(K)Number K001245  
Product Classification Cpb check valve, retrograde flow, in-line - Product Code MJJ
Product Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035NS QUANTITY: 100, DESCRIPTION: NONADJUSTABLE VENT VALVE, NON-STERILE; AND and 3-T Medical Systems, Catalog #035NS, Non-Adjustable One Way Vent Valve, Quantity: 100, NON-STERILE

The TrueChoice and 3-T Vacuum Control One-Way Vent Valve is indicated for use during cardiopulmonary bypass surgery to help prevent the buildup of excess vacuum pressure when suctioning either from the heart or the surgical field, and to help prevent inadvertent retrograde flow and air to the heart.
Code Information Lot # 2011-06-18 thru 2014-06-01
Recalling Firm/
Manufacturer		 Alliant Enterprises LLC
8850 M 89
Richland MI 49083-8558
For Additional Information Contact Mrs. Rebecca Hudson
269-629-0300 Ext. 226
Manufacturer Reason
for Recall		 The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding the 2 halves of the vent valve together.
FDA Determined
Cause 2		 Other
Action Alliant Healthcare sent an URGENT: MEDICAL DEVICE RECALL letter on 7/21/2011 and 7/25/2011. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately review the recall notification and quarantine any affected product. If product was further distributed, customers were to forward the letter with the Recall Return Response Form immediately to all affected locations and indicate which locations on the Recall Return Response Form. Customers were also instructed to discontinue use immediately, dispose of the affected product per their normal disposal protocol, and fax the Recall Return Response Form to Alliant Healthcare Products at 269-629-5770. Upon receipt of the Recall Return Response Form, a substitute vent valve (non-adjustable only) will be sent to their location for each affected product for which disposal has been properly documented in writing. For questions call 269-629-0300, ext 226.
Quantity in Commerce 178 boxes of 100
Distribution Worldwide Distribution - USA including Michigan, Tennessee, New York, and California and the countries of Chile and Korea
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 = MJJ and Original Applicant = 3T MEDICAL SYSTEMS, LLC.
-
-