BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
FDA Device Recall #Z-0057-2020 — Class II — May 13, 2019
Recall Summary
| Recall Number | Z-0057-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 13, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson & Company |
| Location | Franklin Lakes, NJ |
| Product Type | Devices |
| Quantity | N/A |
Product Description
BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
Reason for Recall
Damaged reservoir may lead to a decreased fill volume causing samples to be insufficient for testing and improper blood-to-additive ratio, potentially producing erroneous results.
Distribution Pattern
Nationwide Foreign: AR AU BE BN BR CA CL CN CO CR CW EC GT GY HK HN ID IN JP KR MX MY NI NZ PA PE PG PH PK SG SR SV TH TW UY VN
Lot / Code Information
Lot Number/UDI: 8101695 (01)30382903659747 (17)190930(10)8081695(30)50 (17)190930(10)8101695(30)200(01)50382903659741 8101696 (01)30382903659747 (17)190930(10)8081696(30)50 (17)190930(10)8101696(30)200(01)50382903659741 8101699 (01)30382903659747 (17)190930(10)8101699(30)50 (17)190930(10)8101699(30)200(01)50382903659741 8101701 (01)30382903659747 (17)190930(10)8101701(30)50 (17)190930(10)8101701(30)200(01)50382903659741 8106835 (01)30382903659747 (17)190930(10)8106835(30)50 (17)190930(10)8106835(30)200(01)50382903659741 8106837 (01)30382903659747 (17)190930(10)8106837(30)50 (17)190930(10)8106837(30)200(01)50382903659741 8106842 (01)30382903659747 (17)190930(10)8106842(30)50 (17)190930(10)8106842(30)200(01)50382903659741 8106847 (01)30382903659747 (17)190930(10)8106847(30)50 (17)190930(10)8106847(30)200(01)50382903659741 8106850 (01)30382903659747 (17)190930(10)8106850(30)50 (17)190930(10)8106850(30)200(01)50382903659741 8120851 (01)30382903659747 (17)191031(10)8120850(30)50 (17)191031(10)8120850(30)200(01)50382903659741 8121979 (01)30382903659747 (17)191031(10)8121979(30)50 (17)191031(10)8121979(30)200(01)50382903659741 8121981 (01)30382903659747 (17)191031(10)8121981(30)50 (17)191031(10)8121981(30)200(01)50382903659741 8124783 (01)30382903659747 (17)191031(10)8124783(30)50 (17)191031(10)8124783(30)200(01)50382903659741 8124880 (01)30382903659747 (17)191031(10)8124880(30)50 (17)191031(10)8124880(30)200(01)50382903659741 8127770 (01)30382903659747 (17)191031(10)8127770(30)50 (17)191031(10)8127770(30)200(01)50382903659741 8128575 (01)30382903659747 (17)191031(10)8128575(30)50 (17)191031(10)8128575(30)200(01)50382903659741 8129642 (01)30382903659747 (17)191031(10)8129642(30)50 (17)191031(10)8129642(30)200(01)50382903659741 8129645 (01)30382903659747 (17)191031(10)8129645(30)50 (17)191031(10)8129645(30)200(01)50382903659741 8197705 (01)30382903659747 (17)191231(10)8197705(30)50 (17)191231(10)8197705(30)200(01)50382903659741 8197970 (01)30382903659747 (17)191231(10)8197970(30)50 (17)191231(10)8197970(30)200(01)50382903659741 8198921 (01)30382903659747 (17)191231(10)8198921(30)50 (17)191231(10)8198921(30)200(01)50382903659741 8198927 (01)30382903659747 (17)191231(10)8198927(30)50 (17)191231(10)8198927(30)200(01)50382903659741 8243545 (01)30382903659747 (17)200229(10)8243545(30)50 (17)200229(10)8243545(30)200(01)50382903659741 8247628 (01)30382903659747 (17)200229(10)8247628(30)50 (17)200229(10)8247628(30)200(01)50382903659741 8248705 (01)30382903659747 (17)200229(10)8248705(30)50 (17)200229(10)8248705(30)200(01)50382903659741 8249986 (01)30382903659747 (17)200229(10)8249986(30)50 (17)200229(10)8249986(30)200(01)50382903659741 8288904 (01)30382903659747 (17)200331(10)8288904(30)50 (17)200331(10)8288904(30)200(01)50382903659741 8290928 (01)30382903659747 (17)200331(10)8290928(30)50 (17)200331(10)8290928(30)200(01)50382903659741"
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Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.