Recall Z-0794-2020 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corporation
ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - 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. This device is
| Date | Dec 12, 2019 |
| Status | Open, Classified |
| Reason | Continu-Flo sets with male Luer bodies at the lower end of, and within, the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector. |
| Root cause | Device Design |
| Action | The firm disseminated an urgent medical device correction notice on 12/12/2019. The notice explained the issue and provided the following actions be taken: 1. Baxter will be tightening its internal specifications for the D mold to produce Luers that target the mid to upper range of the ISO specification (target date December 2019). Additional actions, as needed, will be determined through investigation. 2. If you purchased this product directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by faxing it to 224-270-5457 or scanning and e-mailing it to f |
| Quantity | 43,495,400 units |
| Distribution | Worldwide distribution - US Nationwide distribution and countries of Bermuda, Bahamas, Trinidad and Tobago, Grand Cayman, St. Thomas, Guyana and Barbados, Mexico, Canada, and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K961225 | CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET Baxter Healthcare Corp, Jun 21, 1996 |