BD Connecta Stopcocks Recalled for Non-U.S. Instructions Shipped to U.S. Market
BD Connecta Luer-Lok 360 stopcocks were distributed with non-U.S. instructions for use. Healthcare facilities should verify they have the correct U.S. instructions before using affected lot numbers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product (IV therapy and hemodynamic monitoring device) where no injury has yet been reported, matching the criterion for High severity.
Plain-English summary
BD Connecta BD Luer-Lok 360 stopcocks, control valves used in IV therapy and hemodynamic pressure monitoring, were shipped to the U.S. market with instructions intended for use outside the United States. The manufacturer, BD SWITZERLAND SARL, is recalling specific lot numbers due to this mislabeling issue.
The affected lot numbers are: 4277968, 4277973, 4282451, 4282461, 4289801, 4290582, 4292904, 4295848, 4305108, and 4306700. These devices were distributed to healthcare facilities in AK, AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WV.
Healthcare facilities and users should immediately verify that their BD Connecta stopcocks bear the U.S. product instructions for use before administering to patients. Contact BD SWITZERLAND SARL or the FDA for the correct U.S. instructions if you possess devices from the affected lot numbers.
The recalled product
- Product
- BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and 3-way Stopcocks are control valves for use in IV. therapy and hemodynamic pressure monitoring.
- Manufacturer
- BD SWITZERLAND SARL
- Category
- Medical Device
- Hazard
- mislabeling
- improper-use
Distribution
Distributed in 35 states:
- AK
- AL
- AR
- AZ
- CA
- CO
- FL
- GA
- IL
- IN
- KS
- KY
- LA
- MA
- MD
- MI
- MN
- MO
- MS
- NC
- NE
- NJ
- NM
- NV
- OH
- OK
- OR
- PA
- SC
- TN
- TX
- UT
- VA
- WA
- WV
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