FDA Recall Terminated

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.

Recall: Z-1102-2021 · Initiated December 21, 2020

Recall

Recall Number
Z-1102-2021
Event Number
87056
Firm
Baxter Healthcare Corporation
FEI Number
1417572
Product Code
FPA
Status
Terminated
Root Cause
Process design
Initiated
December 21, 2020
Terminated
July 11, 2024
Address
1 Baxter Pkwy, Deerfield, IL, 60015-4625

Description

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.

Reason

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

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

Distribution

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

Quantity

66,800 units