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U.S. Department of Health and Human Services

Class 2 Device Recall BD Microtainer Z (No Additive Tubes)

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  Class 2 Device Recall BD Microtainer Z (No Additive Tubes) see related information
Date Initiated by Firm May 13, 2019
Create Date October 07, 2019
Recall Status1 Terminated 3 on August 06, 2020
Recall Number Z-0054-2020
Recall Event ID 82851
510(K)Number K991702  K002456  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product BD Microtainer Z (No Additive Tubes)
Part/Catalog No.365963
Code Information Lot Number/UDI: 8117750 (01)30382903659631 (17)191031(10)8117750(30)50 (17)191031(10)8117750(30)200 (01)50382903659635  8155792 (01)30382903659631 (17)191130(10)8155792(30)50 (17)191130(10)8155792(30)200 (01)50382903659635   8223778 (01)30382903659631 (17)200131(10)8223778(30)50 (17)200131(10)8223778(30)200 (01)50382903659635   8223779 (01)30382903659631 (17)200131(10)8223779(30)50 (17)200131(10)8223779(30)200 (01)50382903659635  8268514 (01)30382903659631 (17)200229(10)8268514(30)50 (17)200229(10)8268514(30)200 (01)50382903659635
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact SAME
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
Action Becton 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).
Distribution 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
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JKA and Original Applicant = BECTON DICKINSON VACUTAINER SYSTEMS
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