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U.S. Department of Health and Human Services

Class 2 Device Recall BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010

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  Class 2 Device Recall BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010 see related information
Date Initiated by Firm March 07, 2019
Create Date April 10, 2019
Recall Status1 Terminated 3 on May 12, 2020
Recall Number Z-1122-2019
Recall Event ID 82317
510(K)Number K972404  
Product Classification Tubes, vials, systems, serum separators, blood collection - Product Code JKA
Product BD Blood Collection Assembly with Male Luer Lock, Catalog Number MBC6010
Code Information Lot Numbers, UDI: 18041501, (17)210315(10)18041501, (01)50885403235915.   18042501, (17)210325(10)18042501, (01)50885403235915.   18050501, (17)210405(10)18050501, (01)50885403235915.   18051501, (17)210415(10)18051501, (01)50885403235915.   18052501, (17)210425(10)18052501, (01)50885403235915.   18060501, (17)210505(10)18060501, (01)50885403235915.   18061501, (17)210515(10)18061501, (01)50885403235915.   18062501, (17)210525(10)18062501, (01)50885403235915.   18070501, (17)210605(10)18070501, (01)50885403235915.   18072501, (17)210625(10)18072501, (01)50885403235915.   18080501, (17)210705(10)18080501, (01)50885403235915.   18081501, (17)210715(10)18081501, (01)50885403235915. 
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact
888-237-2762
Manufacturer Reason
for Recall		 The luer could break and cause the device to leak or break off and get stuck in the fistula needle port rendering the port inaccessible for dialysis. As a result, the patient would need to be re-cannulated with a new fistula needle to obtain their dialysis treatment.
FDA Determined
Cause 2		 Process change control
Action Urgent Medical Device Recall notification letters dated 3/7/19 were distributed to customers.
Quantity in Commerce 6,509,600
Distribution US distribution to the states of FL and NJ.
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 = BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
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