BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
- Company
- Becton Dickinson & Company
- Recall Initiated
- May 9, 2022
- Recall Number
- Z-1432-2022
- Quantity
- 2800270
- 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: 382903946006 Lot Numbers/Exp. Date: 1126369 4/30/2024 1126368 4/30/2024 1152277 5/31/2024 1126371 4/30/2024 1152275 5/31/2024 1126366 4/30/2024 1124513 4/30/2024 1126361 4/30/2024 1214381 7/31/2024 1123653 4/30/2024 1123644 4/30/2024 1098342 3/31/2024 1098335 3/31/2024 1098339 3/31/2024 1085949 2/29/2024 1098333 3/31/2024 1090036 2/29/2024 1085634 2/29/2024 1085635 2/29/2024 1090038 2/29/2024 1090820 2/29/2024 1083414 2/29/2024 1063420 2/29/2024 1063419 2/29/2024 1063417 2/29/2024 1060787 2/29/2024 1060784 2/29/2024 1033322 1/30/2024 1060783 2/29/2024 1060791 2/29/2024
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