Z-3070-2024 Class II Ongoing
FDA device recall Z-3070-2024 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: 485 units.
Recall Details
- Product Type
- Devices
- Report Date
- Sep 18, 2024
- Initiation Date
- Jun 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 485 units
Product Description
KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
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 40195327060412, UDI/DI Each 10195327060411; Lot Numbers: 23ILA372, 23ILA184, 23HLB240, 23HLA567, 23HLA126, 23ELA634, 23DLA974, 23ALA995, 22JLA577, 22HLA985, 22HLA379, 22GLB224, 22GLB099, 22GLA383, 22GLA171, 22DLA615, 22CLA957, 22ALA965, 22ALA325
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-3070-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026