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U.S. Department of Health and Human Services

Class 2 Device Recall CLEARLINK System NonDEHP Microbore Three Lead Catheter Extension Set with LAV

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 Class 2 Recall
CLEARLINK System NonDEHP Microbore Three Lead Catheter Extension Set with LAV
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Date Posted October 29, 2013
Recall Status1 Open
Recall Number Z-0099-2014
Recall Event ID 66238
Premarket Notification
510(K) Number
K112893 
Product Classification Set, Administration, Intravascular - Product Code FPA
Product Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids.
Code Information UR13C11089, UR13D16060
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
1 Baxter Pkwy
Deerfield, Illinois 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Under Investigation by the firm
Action Baxter sent an Urgent Product Recall letter dated September 9, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken by Customer/User: 1. Locate and remove all affected product from your facility. If you distribute these products to other facilities or departments within your institution, please forward a copy of this communication to ensure that they locate and remove affected product from potential use. The product code and lot number can be found on the shipping carton label and individual product package. 2. Acknowledge your receipt of this recall notification by completing the attached Customer Reply Form (Attachment 1) and return it to Baxter by either faxing it to 224-270-5457 or scanning and emailing it to fca@baxter.com. Returning the Customer Reply Form promptly will prevent you from receiving repeat notifications. 3. The affected product should be returned for credit by contacting Baxter Healthcare Center for Service. The Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time. Please have your Baxter eight-digit ship-to account number ready when calling.Please have the product code and lot number(s) available.
Quantity in Commerce 3,200 units
Distribution US Distribution including the states of OK, GA, CA, MN, TX and HI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = BAXTER HEALTHCARE CORPORATION
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