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 waste tubing

  • 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 waste tubingsee related information
Date Initiated by FirmMay 22, 2006
Date PostedJuly 26, 2006
Recall Status1 Terminated 3 on April 17, 2012
Recall NumberZ-1260-06
Recall Event ID 35695
Product Classification waste tubing - Product Code CHL
ProductModel #842-326 (pump tube for waste) & Model #842-327 (pump tube for solution), Waste Tubing used on ABL 7xx and ABL8xx, component of the ABL700/800 Blood Gas Analyzers, also included in service kits part no. 905-671
Code Information Model #842-326 & Model #842-327, no lot numbers supplied.
FEI Number 1523456
Recalling Firm/
Manufacturer		 Radiometer America Inc
810 Sharon Dr
Westlake OH 44145-1598
For Additional Information Contact
440-871-8900
Manufacturer Reason
for Recall		An increased failure rate was observed with the yellow rubber tubing. The tubing was found to be leaking blood and solutions after distribution.
FDA Determined
Cause 2		Other
ActionThe recalling firm issued a letter to their customers dated 5/22/2006. The letter informs the customer(s) of the tubing defect and provides the customer with one (1) tubing to deal with any immediate needs which they may have. Should the customer require additional waste pump tubing replacements, the letter is accompanied by a FAX FORM which can be used to request any amount of additional replacement tubing required. The letter also shows tthe address to which the replacement tubing is to be delivered, and provides a Purchase Order request to be used, if required.
Quantity in Commerce2500 Units in U.S. & 76 Units in Canada
DistributionNationwide to user/customers in the U.S. and in Canada
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.
-
-