ClearanceBrief
Recall Z-0948-2022 ยท KYX Dispenser, Liquid Medication

Baxter Healthcare Corporation

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

DateFeb 25, 2022
StatusTerminated
ReasonProduct is mislabeled as self-righting Luer slip tip caps, yellow.
Root causeMixed-up of materials/components
ActionThe 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 practic
Quantity5,500 DISCPACs (100/DISCPAC).
DistributionWorldwide 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.