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 RespVent

  • 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 RespVentsee related information
Date Initiated by FirmAugust 19, 2019
Create DateMarch 05, 2020
Recall Status1 Open3, Classified
Recall NumberZ-1443-2020
Recall Event ID 84859
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
ProductRespVent Closed Suction System T-Piece Tracheostomy Adult, Diameter: 4.6mm (14F), Length: 30.5cm (12in.), MDI Adapter, Cont. 10 Closed Suction Catheter, Sterile R, RxOnly, Reorder Number: RTG-02300, UDI: 00850108006035 - Product Usage: To be used to aspirate liquids or semi solids from a patient s upper airway.
Code Information Lot KS1901013: 20019/03/31 - 06/192019 Lot KS1902002: 2019/06/21 - 07/31/2019 
FEI Number 3011285025
Recalling Firm/
Manufacturer		 RESPIRATORY THERAPEUTICS GROUP LLC
5670 Wilshire Blvd Ste 1803
Los Angeles CA 90036-5679
For Additional Information ContactJacob Shallman
310-402-8962
Manufacturer Reason
for Recall		It has been determined that some units of catheters were not tightly connected to the thumb port. This may result in the catheter disconnecting from the thumb port which could reduce the suction performance and make it difficult to remove from the patient's trachea.
FDA Determined
Cause 2		Component change control
ActionOn 8/19/19 a recall notice was sent to all affected customers. The letter outlined the recall issue and requested that customers complete the enclosed form for the return of the products (new and used) and the issuance of replacement product or credit.
Quantity in Commerce723 cases (7230 units)
DistributionUS Nationwide distribution in the states of CA, NJ, NY. OUS: None
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-