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Class 2 Device Recall BD Connecta |
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Date Initiated by Firm |
May 09, 2022 |
Create Date |
July 21, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1434-2022 |
Recall Event ID |
90304 |
510(K)Number |
K974083
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Product Classification |
Stopcock, i.V. Set - Product Code FMG
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Product |
BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS) |
Code Information |
GTIN:
382903946020
Lot Numbers/Exp.Date:
1152283 5/31/2024
1113643 3/31/2024
1120601 3/31/2024
1113657 3/31/2024
1098327 3/31/2024
1124487 4/30/2024
1098376 3/31/2024
1098372 3/31/2024
1097651 3/31/2024
1098181 3/31/2024
1098379 3/31/2024
1085636 2/29/2024
1085897 2/29/2024
1097647 3/31/2024
1061613 2/29/2024
1063398 2/29/2024
1090040 2/29/2024
1097641 3/31/2024
1097637 3/31/2024
1098371 3/31/2024
1090039 2/29/2024
1085895 2/29/2024
1063392 2/29/2024
1090052 2/29/2024
1061609 2/29/2024
1084430 2/29/2024
1061606 2/29/2024
1063402 2/29/2024
1063369 2/29/2024
1063367 2/29/2024
1063370 2/29/2024
1063390 2/29/2024
1063368 2/29/2024
1063389 2/29/2024
1063366 2/29/2024
1033529 1/31/2024
1040952 1/31/2024
1040913 1/31/2024
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Recalling Firm/ Manufacturer |
Becton Dickinson & Company 1 Becton Dr Franklin Lakes NJ 07417-1815
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For Additional Information Contact |
SAME 201-847-6800
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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.
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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 |
2,100,210 |
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
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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.
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510(K) Database |
510(K)s with Product Code = FMG and Original Applicant = OHMEDA MEDICAL
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