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 an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.
Recall
- Recall Number
- Z-0794-2020
- Event Number
- 84511
- Firm
- Baxter Healthcare Corporation
- FEI Number
- 1417572
- Product Code
- FPA
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- December 12, 2019
- Address
- 1 Baxter Pkwy, Deerfield, IL, 60015-4625
Description
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 an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.
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.
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 [email protected], even if you do not have any inventory. Returning the Baxter customer reply form promptly will prevent you from receiving repeat notices. 3. If you purchased this product from a distributor, please note that the Baxter customer reply form is not applicable. If a reply form is provided by your distributor or wholesaler, please return it to the supplier according to their instructions. 4. If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them. 5. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please distribute this notification to customers and check the associated box on the reply form. For general questions regarding this communication, contact Baxter Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday.
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.
43,495,400 units