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 Recall Z-1102-2021 · Posted None
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Recalling FirmBaxter Healthcare Corporation
Recall StatusTerminated
Product CodeFPA
Date Initiated2020-12-21
Date Terminated2024-07-11
Product Quantity66,800 units
Reason for Recall
There were customer reports of separation between the tubing and Male Luer Lock Adaptor.
Firm 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
Root Cause
Process design
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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