—#185138

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.

FDA product code: FPA — Set, Administration, Intravascular
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K132734
Affected lot / code info: 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

Why it was recalled

There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

Root cause (FDA determination)

Process design

Action the firm took

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

Recalling firm

Firm: Baxter Healthcare Corporation
Address: 1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.

Timeline

Recall initiated: 2020-12-21
Terminated: 2024-07-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185138. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.