Z-0165-2023 Class II Ongoing
FDA device recall Z-0165-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Sep 30, 2022 and is designated Class II. Reason for recall: Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal. The recall status is ongoing. Affected quantity: 240 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 9, 2022
- Initiation Date
- Sep 30, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240 kits
Product Description
MEDLINE RADIOLOGY PROCEDURE PACK, REF DYNJ67150A. Convenience kit used in medical procedures.
Reason for Recall
Medline received complaints on some of the breather pouches with in the sterile surgical kits show openings in the seal.
Distribution Pattern
US Nationwide distribution in the states of CA, MN, NC, NY, OK, PA, TN, TX.
Code Information
GTIN (01) 10195327027278, Lot Number 22OBK037
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0165-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026