Z-0743-2024Class II

HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP

Name: Z-0743-2024 HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
Creator: Smiths Medical Asd Inc
Published: 2023-11-10
License: https://open.fda.gov/license/

Abbott Medical / initiated 2023-11-10 / Open, Classified / root cause: manufacturing process

FDA source

Smiths Medical Asd Inc began a recall of HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP on 2023-11-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0743-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-10
Posted: 2024-01-17
Recalling firm: Abbott Medical
Product: HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP
Product code: DRS Transducer, Blood-Pressure, Extravascular
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.
Root cause tag: manufacturing process
FDA 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 [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
Quantity in commerce: 31,685 total
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, UAE.
Product codes and lots: Lot Number: 4332915 4408772

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0743-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0739-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17
Z-0740-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17
Z-0741-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17
Z-0742-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17
Z-0743-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17
Z-0744-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17
Z-0745-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17
Z-0746-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17
Z-0747-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-17

Product code DRS

K943897Class IINu-SiteMedex, Inc. / cleared 1995-02-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)