Z-1124-2023 Class II Ongoing
FDA device recall Z-1124-2023 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: 1588 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 22, 2023
- Initiation Date
- Dec 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1588 units
Product Description
Surgical convenience kits labeled as: a) CENTURION MEDICAL PRODUCTS CENTRAL LINE DRESSING CHANGE K, Reorder Number DT21400; b) CENTURION MEDICAL PRODUCTS CUSTOM PORT ACCESS KIT, Reorder Number DT22255; c) MEDLINE CVC DRESSING CHANGE KIT, Reorder Number DYNDC1022GB,
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
a) Reorder Number DT21400, GTIN 40653160318225 Lot # 22HMH962; b) Reorder Number DT22255, GTIN 40653160328644 Lot # 22HMH427; c) Reorder Number DYNDC1022GB, GTIN 40195327038701 Lot # 22GBY236
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1124-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026