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U.S. Department of Health and Human Services

Class 2 Device Recall BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor

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 Class 2 Device Recall BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitorsee related information
Date Initiated by FirmMay 13, 2019
Create DateOctober 07, 2019
Recall Status1 Terminated 3 on August 06, 2020
Recall NumberZ-0061-2020
Recall Event ID 82851
510(K)NumberK002456 K991702 
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
ProductBD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA) Glycolytic Inhibitor Part/Catalog Number: 365992
Code Information Lot Number/UDI: 8212777 (01)30382903659921 (17)191031(10)8212777(30)50 (17)191031(10)8212777(30)200(01)50382903659925   8212785 (01)30382903659921 (17)191031(10)8212785(30)50 (17)191031(10)8212785(30)200(01)50382903659925   8268546 (01)30382903659921 (17)191130(10)8268546(30)50 (17)191031(10)8268546(30)200(01)50382903659925   8268549 "(01)30382903659921 (17)191130(10)8268549(30)50 (17)191130(10)8268549(30)200(01)50382903659925  
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information ContactSAME
201-847-6800
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionBecton Dickinson (BD) notified consignees affected by letter via UPS and email dated May 13,2019. Letter describes reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific catalog and lot numbers listed below, 2. Destroy all product subject to the recall following your institution's process for destruction, 3. Share this Urgent Medical Device Recall notification with all users of the product to ensure that they are also aware of this recall, and 4. Complete the attached Customer Response/Certificate of Destruction Forms and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement. Distributors provide their customer list to BD. BD PAS will notify these customers via mail. BD Contact US Contact Information Customer/Technical Support 888-237-2762 OPT 3, OPT 2; Monday  Friday 8:00am - 5:00pm (CT).
DistributionNationwide 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
Total Product Life CycleTPLC 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = JKA
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