BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
Recall
- Recall Number
- Z-1431-2022
- Event Number
- 90304
- Firm
- Becton Dickinson & Company
- FEI Number
- 2243072
- Product Code
- FMG
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- May 9, 2022
- Address
- 1 Becton Dr, Franklin Lakes, NJ, 07417-1815
Description
BD Connecta Stopcock with OFF Directed Tap Without Extension Tube (500 eaches/carton) Catalog No. 394910 (US)
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.
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 [email protected] General Follow-up, Product Complaints, Technical Questions
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.
485,000 units