Recalls / —

—#192208

Product

Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow, REF H93866100, 100 slip tip caps/package.

FDA product code

KYX — Dispenser, Liquid Medication

Device class

Class 1

Medical specialty

General Hospital

Affected lot / code info

Lot numbers 60268365, 60268609, 60268610, exp. date 10/31/2023; UDI 0085412478852.

Why it was recalled

Product is mislabeled as self-righting Luer slip tip caps, yellow.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

The recalling firm issued letters dated 2/25/2022 via first class mail to the U.S. consignees. The letter explained the reason for recall, described the affected product, the hazard involved, and the actions to be taken by the customer. Those actions included to immediately check their inventory and segregate the affected product, which had a notation that if there are Luer lock tip caps co-mingled with Luer slip tip caps in the same DISCPAC container, please discard the DISCPAC container and that tip caps that are not co-mingled can continue to be used safely following good pharmacy practices. If the consignee received the letter directly from Baxter, they are to acknowledge receipt by responding on the customer portal. If the product was purchased from a distributor, they only need to respond to the distributor or wholesaler according to their instructions. If the product was further distributed to other facilities or departments within their institution, they were instructed to forward a copy of the letter to them. If the customer is a dealer, wholesaler, distributor/reseller, or original equipment manufacturer that distributed the affected product to other facilities, they are to distribute the notification to them. A Reply Form Instruction Sheet was enclosed which outlined the details of the affected product and Baxter Field Action Portal Acknowledgement Instructions. Notification of OUS consignees began 2/25/2022 via mail, email, or FAX.

Recalling firm

Firm

Baxter Healthcare Corporation

Address

1 Baxter Pkwy, Deerfield, Illinois 60015-4625

Distribution

Distribution pattern

Worldwide distribution - US Nationwide distribution in the states of FL, GA, IL, IN, MO, PA, TX, and VA. The countries of Canada, Austria, Germany, Netherlands, Qatar, Saudi Arabia, and Spain.

Timeline

Recall initiated

2022-02-25

Terminated

2026-03-02

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #192208. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.