Z-0123-2023 Class II Ongoing
FDA device recall Z-0123-2023 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: 760 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 2, 2022
- Initiation Date
- Sep 9, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 760 kits
Product Description
MEDLINE 24 BLOOD CLUTURE KIT, Reorder #: DYNDH1632
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)40193489916141 (case), (01)10193489916140 (kit), Lot Number: 22FMF305
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0123-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026