FDA Medical Device Recalls (openFDA)
Smiths Medical Asd Inc: Medex LOGICAL CATH LAB KIT, List Number M20754
- Recall number
- Z-0739-2024
- Recalling firm
- Smiths Medical Asd Inc
- Product
- Medex LOGICAL CATH LAB KIT, List Number M20754
- Status
- Open, Classified
- Initiated
- 2023-11-10
- Posted
- 2024-01-17
- Terminated
- not on file
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- 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
- Quantity
- 31,685 total
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, UAE.
- Lot, serial or model codes
- UDI-DI: 10351688510686; Lot Number: 4371054
- 510(k) numbers
- ["K820355"]
- PMA numbers
- not on file
- Product code
- DRS
- Firm FEI
- 1526863
- Firm city
- Dublin
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28