Z-0095-2023 Class II Ongoing
FDA device recall Z-0095-2023 was initiated by Becton Dickinson & Company on Sep 15, 2022 and is designated Class II. Reason for recall: The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive… The recall status is ongoing. Affected quantity: 2,196,000.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 26, 2022
- Initiation Date
- Sep 15, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,196,000
Product Description
BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg, Catalog Number 367001. For collecting, transporting, separating, and processing blood for blood alcohol determination.
Reason for Recall
The affected product contains isobutylene which has recently demonstrated potential interference in determination of methanol by gas chromatography methods. The interference may lead to false positive results in methanol testing.
Distribution Pattern
Distribution US nationwide, Canada, New Zealand, and Hong Kong.
Code Information
UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0095-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026