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U.S. Department of Health and Human Services

Class 2 Device Recall BD Connecta" Stopcocks

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  Class 2 Device Recall BD Connecta" Stopcocks see related information
Date Initiated by Firm May 09, 2022
Create Date July 21, 2022
Recall Status1 Open3, Classified
Recall Number Z-1433-2022
Recall Event ID 90304
510(K)Number K974083  
Product Classification Stopcock, i.V. Set - Product Code FMG
Product BD Connecta Stopcock Without Extension Tube
Catalog No. 394601 (OUS)
Code Information GTIN: 382903946013 Lot Numbers/Exp.Date: 1126398 4/30/2024 1127180 4/30/2024 1127179 4/30/2024 1123685 4/30/2024 1119049 3/31/2024 1126395 4/30/2024 1123679 4/30/2024 1098302 3/31/2024 1123674 4/30/2024 1098301 3/31/2024 1123683 4/30/2024 1123682 4/30/2024 1123670 4/30/2024 1098294 3/31/2024 1098278 3/31/2024 1098283 3/31/2024 1098276 3/31/2024 1090041 2/29/2024 1089729 2/29/2024 1089723 2/29/2024 1098266 3/31/2024 1098272 3/31/2024 1090046 2/29/2024 1090043 2/29/2024 1061602 2/29/2024 1061605 2/29/2024 1033538 1/31/2024 1033511 1/31/2024 1033539 1/31/2024 1033514 1/31/2024 1034769 1/31/2024 1033518 1/31/2024 1034649 1/31/2024 1061584 2/29/2024 1061594 2/29/2024 1061601 2/29/2024 1033510 1/31/2024 1033541 1/31/2024 1033542 1/31/2024 1034656 1/31/2024 1040916 1/31/2024 1061596 2/29/2024 1061598 2/29/2024
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		 May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination and/or air ingress.
FDA Determined
Cause 2		 Under Investigation by firm
Action BD notified consignees Medical Device Field Correction Notice on 5/9/22 via mail/email. Firm issued Urgent Medical Device Field Correction Letter extended to additional lots on July 13, 2022 via email. Letter states reason for recall, health risk and action to take: Please Take the Following Actions: 1. Inspect your inventory, locate and quarantine any units of the impacted lot numbers and destroy all affected product. 2. For Clinical Users: ¿ For devices in situ, check to see if the device is within scope of this Field Safety Notice and replace immediately. ¿ If you are unable to determine if the device is within scope, replace the device or continue to monitor for leakage and/or other complications. 3. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 4. Complete the attached Customer Response Form 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 per FDA requirements and subsequently process your product replacement. North American Regional Complaint Center 1-844-8BD-LIFE (1-844-823-5433) Say Recall when prompted Mon Fri 8:00am and 5:00pm CT for productcomplaints@bd.com General Follow-up, Product Complaints, Technical Questions
Quantity in Commerce 1,960,360
Distribution Worldwide distribution - US Nationwide distribution in the states of AK, AR, AZ, CA, CO, FL, GA, IL, IN, KS, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SD, TN, TX, UT, VA, WA, WV and the countries of Belgium, China, India, Indonesia, Japan, Korea, Nepal, Philippines, Singapore, Sri Lanka, Thailand, Vietnam.
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.
510(K) Database 510(K)s with Product Code = FMG and Original Applicant = OHMEDA MEDICAL
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