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 Continuous flush device

  • 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 Continuous flush device see related information
Date Initiated by Firm July 01, 2005
Date Posted October 21, 2005
Recall Status1 Terminated 3 on August 09, 2011
Recall Number Z-0070-06
Recall Event ID 33316
510(K)Number K791844  
Product Classification Catheter, Continuous Flush - Product Code KRA
Product CRITIFLOW(tm) TA4004 continuous flush catheter
Code Information Part Number 682060.Lot numbers: 012485, 101226, 102036, 103011, 103370, 106015, 107041, 108033, 109060, 110004, 111037, 201056, 204002, 205041, 206026, 207062, 208073, 211376, 212407, 301104, 302256, 303085, 303246, 304562, 306211, 306443, 308071, 308169, 308518, 309086, 310124, 311143, 312418, 403315, 404050, 405097, 407055, 407468, 408018.
Recalling Firm/
Manufacturer		 Becton Dickinson Medical Systems
9450 S State St
Sandy UT 84070-3213
For Additional Information Contact
801-565-2341
Manufacturer Reason
for Recall		 Device could permit an over-infusion of IV solutions during pressure monitoring procedures.
FDA Determined
Cause 2		 Other
Action Consignees were notified by letter on 8/22/2005 and told to immediately locate and quarantine all affected product for return to BD. Customer Recall Response Card was to completed and returned. For questions concerning the recall, call 800-453-4538 between 8AM and 5PM MST.
Quantity in Commerce 20,165 units
Distribution Nationwide, including PR. VA facilities in OH, WA, NV and NY. No military or foreign distribution by US firm..
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 = KRA and Original Applicant = GOULD, INC.
-
-