Medex LOGICAL CATH LAB KIT, List Number M20754

FDA device recall Z-0739-2024 · posted 2024-01-17 · Open, Classified

Recall details

Recalling firm

Smiths Medical Asd Inc

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.

Action taken

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

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

DRS

Quantity affected

31,685 total

Distribution

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

Date initiated

2023-11-10

Date posted

2024-01-17

Location

Dublin, OH

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