Z-0122-2023 Class II Ongoing
FDA device recall Z-0122-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Sep 9, 2022 and is designated Class II. Reason for recall: Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle… The recall status is ongoing. Affected quantity: 1600 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 2, 2022
- Initiation Date
- Sep 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1600 kits
Product Description
MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592
Reason for Recall
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.
Distribution Pattern
US Nationwide distribution in the state of California.
Code Information
UDI/DI (01)40193489497220 (case), (01)10193489497229 (kit), Lot Numbers: 22GME974, 22FMF309
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0122-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026