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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter ONELINK NonDEHP YType Microbore Catheter Extension Set

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  Class 2 Device Recall Baxter ONELINK NonDEHP YType Microbore Catheter Extension Set see related information
Date Initiated by Firm December 21, 2020
Create Date February 09, 2021
Recall Status1 Completed
Recall Number Z-1102-2021
Recall Event ID 87056
510(K)Number K132734  
Product Classification Set, administration, intravascular - Product Code FPA
Product Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use.
Code Information UDI: 00085412613505, Lot Numbers: DR18E01023, exp. 5/2/2023; DR18E07053, exp. 5/8/2023; DR19G08023, exp. 7/8/2024; DR19H07015, exp. 8/7/2024; DR19L09030, exp. 12/10/2024; DR20B04020, exp. 2/5/2025
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
FDA Determined
Cause 2		 Process design
Action The firm initiated the recall by email on 12/21/2020. The letter requested the following: 1. Locate and remove the affected product from consignee's 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. 3. Confirm the receipt of the letter by completing the enclosed Baxter customer reply form and return it to Baxter via email
Quantity in Commerce 66,800 units
Distribution Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.
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.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = BAXTER HEALTHCARE CORP.
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