Baxter Healthcare Corp. Rt. Baxter Non-DEHP High Flow Rate Extension Set, product code 2N3349; An Rx sterile, nonpyrogenic fluid pathway, 60', 2.14mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Baxter Non-DEHP High Flow Rate Extension Set, product code 2N3349; An Rx sterile, nonpyrogenic fluid pathway, 60', 2.14mL Vol, with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.
Brand
Baxter Healthcare Corp. Rt.
Lot Codes / Batch Numbers
product code 2N3349, lots UR258939, UR258996, UR259150, UR259200
Products Sold
product code 2N3349, lots UR258939, UR258996, UR259150, UR259200
Baxter Healthcare Corp. Rt. is recalling Baxter Non-DEHP High Flow Rate Extension Set, product code 2N3349; An Rx sterile, nonpyrogenic fluid due to The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The extension sets contain microbore female luers that may crack during use, resulting in leakage of medication or incomplete delivery of medication.
Recommended Action
Per FDA guidance
Baxter sent Urgent Product Recall letters dated 8/3/05 to their customers, to the attention of the Director of Materials Management, via first class mail on the same date. The accounts were informed of the microbore female luers that may crack during use, resulting in the possible under delivery or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and return it to Baxter for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837. Baxter extended the recall to include additional lots and product codes via letter dated 12/15/05. The letters referenced the 8/3/05 letter, including a copy of that letter, and listed the affected lots of sets. The instructions for return of the product remained the same as that described in the 8/3/05 letter.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026