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 ONELINK NONDEHP YTYPE MICROBORE 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 ONELINK NONDEHP YTYPE MICROBORE CATHETER EXTENSION SET see related information
Date Initiated by Firm May 21, 2015
Date Posted October 16, 2015
Recall Status1 Terminated 3 on May 10, 2017
Recall Number Z-0132-2016
Recall Event ID 71260
510(K)Number K132734  
Product Classification Set, administration, intravascular - Product Code FPA
Product ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT
Code Information Code: 7N8371, Lots: UR15B16021 and UR15B23043  
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact
847-948-4770
Manufacturer Reason
for Recall		 Potential for a leak at the tubing to luer bond.
FDA Determined
Cause 2		 Packaging
Action Baxter sent their consignees a recall letter dated 05/21/2015 with the following instructions: Actions to betaken if product was purchased directly from Baxter : 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. Please have your Baxter 8-digit ship-to account number, product code, lot number(s) and quantity of product to be returned ready when calling. 3. Complete the ¿enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to fca@baxter.com . Returning the Baxter customer reply form promptly will prevent you from receiving repeat notices. 4. If you distribute this product to other facilities or departm ents within your institution, please forward a copy of this communication to them. 5. If you are a dealer, wholesaler, distributor/reseller, or Original Equipment Manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers. Action to be taken if product was purchased from a distributor: 1. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return and credit. The Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00pm central time, Monday through Friday. 3. Pl ease note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to the
Quantity in Commerce 23,600
Distribution Domestic Only
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 = FPA and Original Applicant = BAXTER HEALTHCARE CORP.
-
-