Z-3072-2024 Class II Ongoing
FDA device recall Z-3072-2024 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Jun 18, 2024 and is designated Class II. Reason for recall: A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that… The recall status is ongoing. Affected quantity: 315 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- Jun 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 315 units
Product Description
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
Reason for Recall
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Distribution Pattern
US: TX, IL, CA
Code Information
UDI/DI Case 40195327334209, UDI/DI Each 10195327334208; Lot Numbers: 23IBJ309, 23GBA500, 23GBA457, 23CBE394, 23BBL312
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3072-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026