Recall Z-1436-2022 ยท FMG Stopcock, I.V. Set
Becton Dickinson & Company
BD Connecta 3-Way Stopcocks Catalog No. 394900 (OUS)
| Date | May 9, 2022 |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | 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 t |
| Quantity | 54010 |
| 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 Lank |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K974083 | CONNECTA PLUS 1 AND CONNECTA PLUS 3 2-WAY AND 3-WAY STOPCOCKS Ohmeda Medical, Jan 13, 1998 |