Recall Z-0743-2024— Smiths Medical Asd Inc

Name: FDA recall Z-0743-2024
Creator: U.S. Food and Drug Administration
Published: 2023-11-10

Class II · Ongoing

Class II FDA medical device recall by Smiths Medical Asd Inc, initiated 2023-11-10. It names one FDA 510(k) clearance: K943897. Product: HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP. Reason: There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication..

Recalling firm: Smiths Medical Asd Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-11-10
Firm location: Dublin, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K943897 — NU-SITEMedex, Inc.·cleared 1995-02-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP

Reason for recall

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Data sourced from openFDA. This site is unofficial and independent of the FDA.