Recalls / —

—#195346

Product

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100

FDA product code

KYX — Dispenser, Liquid Medication

Device class

Class 1

Medical specialty

General Hospital

Affected lot / code info

REF H938671100, UDI 00085412479750

Why it was recalled

There is a potential of the packaging not maintaining a sterile barrier for the tip caps.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Baxter notified its direct consignees by letter on 07/22/2022. The letter explained the issue and potential hazard and provided the following instructions: "1. Locate, isolate/quarantine, and prepare for return any unused affected product from your facility. 2. Contact Baxter Healthcare Center for Service to arrange for return of the products and credit. Baxter Healthcare Center for Service can be reached at 888-229-0001 between the hours of 7:00 am and 6:00 pm Central Time, Monday through Friday. 3. If you received this communication directly from Baxter, please acknowledge receipt of this notification by responding on our customer portal at https://BaxterFieldActionCustomerPortal.onprocess.com, even if you do not have any inventory. Log in to the portal using the account number listed in the enclosed reply form instruction sheet. Acknowledging receipt of this notification will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. If you purchased this product from a distributor or wholesaler, please note that responding on the Baxter customer portal is not applicable. 5. If you distributed this product to other facilities or departments within your institution, please forward a copy of this communication to them. 6. If you are a dealer, wholesaler, distributor/reseller, or original equipment manufacturer (OEM) that distributed any affected product to other facilities, please conduct a consumer-level recall of the affected product that you distributed to customers and check the associated box on the customer portal. For general questions regarding this communication, please contact Baxter Corporate Product Surveillance at 800-437-5176, between the hours of 8:00 am and 5:00 pm Central Time, Monday through Friday."

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

Worldwide distribution: US (nationwide) distribution and OUS (foreign) : Australia, Finland, Germany, Spain and United Kingdom.

Timeline

Recall initiated

2022-07-22

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #195346. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.