Recall Z-1102-2021 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corporation
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.
| Date | Dec 21, 2020 |
| Status | Terminated |
| Reason | There were customer reports of separation between the tubing and Male Luer Lock Adaptor. |
| Root cause | 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 | 66,800 units |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132734 | NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS Baxter Healthcare Corp, Oct 8, 2013 |