BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta¿ Plus 1 and Connecta¿ Plus 3 2-way and
Summary
The FDA issued a Class II for BD Connecta BD Luer-Lok 360, REF 394910 UDI-DI code: 00382903949106 Connecta by BD SWITZERLAND SARL. Reason: Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU).
Details
Source
Device Recall
External ID
Z-1509-2025
Action Date
2025-04-09
Status
Ongoing
Category
device
Product Description
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.
Lot/Code Info: Catalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700
Quantity Affected: 500 units
Reason for Recall
Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
Distribution
U.S.: 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 O.U.S.: N/A
Type: Voluntary: Firm initiated
Recall Initiated: 2025-02-20
Company
Eysins
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 182 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BD SWITZERLAND SARL has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BD SWITZERLAND SARL) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BD SWITZERLAND SARL have FDA actions?
BD SWITZERLAND SARL has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1509-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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