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U.S. Department of Health and Human Services

Class 2 Device Recall BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg

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  Class 2 Device Recall BD Vacutainer Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg see related information
Date Initiated by Firm September 15, 2022
Date Posted October 14, 2022
Recall Status1 Open3, Classified
Recall Number Z-0095-2023
Recall Event ID 90824
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product 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.
Code Information UDI-DI: Case: 50382903670012; Shelf: 30382903670018; Each: 00382903670017; ALL LOTS are affected.
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact North American Regional Complaint Center
844-823-5433
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action On September 15, 2022, the firm notified affected distributors and customers of the recall via Urgent Medical Device Product Advisory letters. Customers were instructed to do the following: 1. Inspect your inventory for the affected catalog number. 2. Ensure the contents of the Product Advisory are read, understood and shared with laboratory management staff having oversight over gas chromatography testing for methanol. Review internal method validations, and if applicable, adjust test practices or settings to avoid potential interference (e.g., implementing the tube as a blank/control, adjustment of GC column and/or operational settings to prevent co-elution, or conversion to dual-column system). 3. If the potential interference cannot be mitigated, stop using the BD Vacutainer¿ Tube Sodium Fluoride: 100 mg, Potassium Oxalate: 20 mg. Product may be returned for credit. The recalling firm will update the IFU to address the potential risk of interference from rubber stopper outgassing in gas chromatography methods. The firm has also initiated corrective and preventive action to investigate root cause and identify actions. If you have further questions, please contact the firm via Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
Quantity in Commerce 2,196,000
Distribution Distribution US nationwide, Canada, New Zealand, and Hong Kong.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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