Device product
BD Connecta Stopcock Without Extension Tube Catalog No. 394600 (OUS)
Z-1432-2022
Product summary
- Event
- Event 90304
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2800270
- Official record key
device-enforcement:Z-1432-2022
Official wording
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.
Code information: 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
Distribution pattern: 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.
Derived failure modes
-
Unknown
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.