Z-1114-2023 Class II Ongoing
FDA device recall Z-1114-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Dec 7, 2022 and is designated Class II. Reason for recall: The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile. The recall status is ongoing. Affected quantity: 60 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 22, 2023
- Initiation Date
- Dec 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 60 units
Product Description
Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
Reason for Recall
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Distribution Pattern
Nationwide
Code Information
GTIN 40193489468510, Lot # 22HMD545
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1114-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026