Medex recallZ-0739-2024 · Smiths Medical Asd Inc · initiated Nov 10, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical Asd Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected] 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 [email protected] 1-(866)-216-8806 Customer Service 1-(800)-258-5361
Recall details
- Recall number
- Z-0739-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 10, 2023
- Posted by the FDA
- Jan 17, 2024
- Recalling firm
- Smiths Medical Asd Inc
- Quantity
- 31,685 total
- Product code
- DRS
- FDA submissions
- K820355
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, UAE.
Product description
Medex LOGICAL CATH LAB KIT, List Number M20754
Code information (models, lots, serial numbers)
UDI-DI: 10351688510686; Lot Number: 4371054
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medex M20754Icu Medical, Inc. · TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR1 recall0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K820355 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Medex MX9604AIcu Medical, Inc. · TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR16 reports
- Medex MX9605AIcu Medical, Inc. · TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR6 reports
- Medex M20178R2Icu Medical, Inc. · TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR3 reports
- Medex MX960XYIcu Medical, Inc. · TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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