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