—#204577

Product

Medex LOGICAL CATH LAB KIT, List Number M20754

FDA product code: DRS — Transducer, Blood-Pressure, Extravascular
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K820355
Affected lot / code info: UDI-DI: 10351688510686; Lot Number: 4371054

Why it was recalled

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.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

An URGENT MEDICAL DEVICE RECALL notification letter dated 11/10/23 was sent to customers. Required Actions for Users: 1. Please discontinue the use and distribution of the affected product immediately. Check your inventory and quarantine all affected product at your facility. 2. Inform potential users of the product in your organization of this notification and complete and return the attached response form to smithsmedical7166@sedgwick.com within ten days of receipt to acknowledge your understanding of this notification, even if you do not have the affected product and/or it has already been used. 3. If you have distributed the product further, immediately notify your accounts that receive the product identified in the Affected Items / Table 1 sections of this notification and ask them to contact Sedgwick at 1-855-215-5142 (MF, 8am-5pm ET) to obtain a response form. 4. If the product has not already been used, please return affected lots to Smiths Medical and Smiths Medical will offer replacement units. Global Complaint Management globalcomplaints@icumed.com 1-(866)-216-8806 Customer Service 1-(800)-258-5361

Recalling firm

Firm: Smiths Medical Asd Inc
Address: 6250 Shier Rings Rd, Dublin, Ohio 43016-1270

Distribution

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

Timeline

Recall initiated: 2023-11-10
Posted by FDA: 2024-01-17
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204577. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.