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 ThinFlex Single Stage Venous Drainage Cannula

  • 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 ThinFlex Single Stage Venous Drainage Cannulasee related information
Date Initiated by FirmMarch 07, 2018
Create DateSeptember 13, 2018
Recall Status1 Terminated 3 on November 27, 2018
Recall NumberZ-3029-2018
Recall Event ID 80317
510(K)NumberK120072 
Product Classification Catheter, cannula and tubing, vascular, cardiopulmonary bypass - Product Code DWF
ProductEdwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
Code Information Code Number TF038L-R; Lot Number 59634935; Serial Numbers 18302172017-01, 18302172017-02, 18302172017-03, 18302172017-04, 18302172017-05, 18302172017-06, 18302172017-07, 18302172017-08, 18302172017-09, 18302172017-10  
Recalling Firm/
Manufacturer		 SPS Sterilization, Inc
1110 N Gerald St
Nixa MO 65714-7445
For Additional Information ContactSteven M. Darocy
412-564-1280
Manufacturer Reason
for Recall		The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
FDA Determined
Cause 2		Labeling False and Misleading
ActionCustomers were notified via letter on about 03/02/2018. Instructions included to review inventory for affected devices, arrange for their return to SPS Sterilization, and complete and return the Buisness Response Card. A follow up letter was sent to customer on about 03/07/2018 and included a description of the risk and hazard involved. Instructions remained the same.
Quantity in Commerce10 units total
DistributionUS distribution to AZ, CA, FL, OH, PA, TX, VA, WV
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DWF
-
-