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 Baxter Catheter Extension Set

  • 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 Baxter Catheter Extension Setsee related information
Date Initiated by FirmSeptember 09, 2010
Date PostedOctober 27, 2010
Recall Status1 Terminated 3 on September 07, 2011
Recall NumberZ-0158-2011
Recall Event ID 56718
510(K)NumberK003225 
Product Classification set, administration, intravascular - Product Code FPA
ProductBaxter Catheter Extension Set, Luer Activated Valve for I.V. Access, Male Luer Lock Adapter, Volume 1.0 mL, Length 6" (15 cm); an Rx sterile device; Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product 2N9191 For the administration of drugs and solutions to a patient's vascular system through a vascular access device.
Code Information product 2N9191, lots U535807R, U535831R, U535906R, U541961R, U568279R, U568543R, U573162R, U573329R, U573535R, U578195R, U578252R, U578278R, U578302R, U578492R, UR108712, UR111575, UR120907, UR121939, UR122069, UR124149, UR127332, UR127506, UR127795, UR131151, UR131748, UR137810, UR140368 and UR142455
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		During packaging testing, Baxter observed tears and pinholes in Chevron-style pouches for certain infusion disposable products. The pinholes and tears could compromise the sterile barrier properties of the pouch.
FDA Determined
Cause 2		Package design/selection
ActionBaxter Healthcare Corporation sent an Urgent Product Recall letter dated September 9, 2010, to all customers. The letter identified the product, the problem and the action to be taken by the customer. The customers were requested to examine their inventory in all locations to determine if they had any of the affected lots of the affected product codes and to remove the affected product from their inventory; they were to call the Baxter Healthcare Center for Service at 1-888-229-0001 to return the affected product, request a credit, or request replacement product; complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number provided on the form. Dealers, wholesalers and distributors were requested to notify their customers of this action so they could comply with the procedures listed above. Any questions regarding the communication were directed to The Center for One Baxter at 1-800-422-9837 during the hours of 8:00 am to 5:00 pm CST.
Quantity in Commerce data not available
DistributionWorldwide Distribution - U.S., Canada, Japan, Australia, New Zealand, and Chile.
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 = FPA
-
-