Smiths Medical Asd Inc: Medical Device Recall in 2024 - (Recall #: Z-0745-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

20IN (50.8CM) BRAIDED INJ LINE, ROTATING ADAPT, List Number MX682BR

Product Classification:

Class II

Date Initiated: November 10, 2023

Date Posted: January 24, 2024

Recall Number: Z-0745-2024

Event ID: 93506

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.

Status: Ongoing

Product Quantity: 31,685 total

Code Information:

Lot Number: 4398428 4404690

Distribution Pattern:

Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Voluntary or Mandated:

Voluntary: Firm initiated