Z-1123-2023 Class II Ongoing
FDA device recall Z-1123-2023 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: 1376 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 22, 2023
- Initiation Date
- Dec 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1376 units
Product Description
Surgical convenience kits labeled as: MEDLINE PREP TRAY, Reorder Number DYNDL1643A
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
Reorder Number DYNDL1643A, GTIN 40888277287809, Lot # 22HMH244
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1123-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026