Z-1120-2023 Class II Ongoing
FDA device recall Z-1120-2023 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: 981 units.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 22, 2023
- Initiation Date
- Dec 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 981 units
Product Description
Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
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 DYNDC2733, GTIN 40888277783974, Lot # 22HMG957; b) Reorder number SUT14640, GTIN 40653160184158, Lot # 22HMG490
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1120-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026