BD Connecta Stopcock Without Extension Tube Catalog No. 394602 (OUS)
- Company
- Becton Dickinson & Company
- Recall Initiated
- May 9, 2022
- Recall Number
- Z-1434-2022
- Quantity
- 2,100,210
- Firm Location
- Franklin Lakes, NJ
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.
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.
Lot / Code Info
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
Root Cause
Under Investigation by firm
Action Taken
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