United StatesBD Connecta Luer-Lok 360 stopcocks (Catalog/REF 394910, UDI-DI 00382903949106; lots 4277968, 4277973, 4282451, 4282461, 4289801, 4290582, 4292904, 4295848, 4299949, 4303841, 4305108, 4306700, 5129635, 5129642, 5129649, 5129650, 5129651, 5139250, 5139251, 5139252, 5150181, 5153940, 5164061, 5164062, 5178078, 5181442, 5183810, 5183816, 5183824, 5183828, 5218287, 5218291, 5218293, 5218299, 5218302, 5241476, 5247729, 5247731, 5251098, 5275601, 5275602) used to administer fluids, sample blood, or for hemodynamic monitoring are recalled. They were recalled because the Port C connection can over‑thread or continue to spin rather than tighten securely, which some clinical users perceived as unstable.
What's being recalled
BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to administer fluids or medication through one or two different ports via an IV cannula or extension tube. The ports can be used to sample blood or for hemodynamic monitoring. When used with IV lipid nutritional products, the stopcock device can be used for up to 24 hours.
Recalling firm: BD Switzerland Sarl, Eysins, Switzerland.
How to identify it
Catalog/Model Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4299949 4303841 4305108 4306700 5129635 5129642 5129649 5129650 5129651 5139250 5139251 5139252 5150181 5153940 5164061 5164062 5178078 5181442 5183810 5183816 5183824 5183828 5218287 5218291 5218293 5218299 5218302 5241476 5247729 5247731 5251098 5275601 5275602
The hazard
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely. This behavior has led some clinical users to perceive the connection as unstable.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
U.S.: AK, AL, AR, AZ, CA, CO, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV. O.U.S.: Japan
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada