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 contr…
BD SWITZERLAND SARL · Due to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU)
Open FDA's page for this record- Cfres ID
- 212777
- Product res number
- Z-1509-2025
- Event date initiated
- 2025-02-20
- Event date posted
- 2025-04-02
- Recall status
- Open, Classified
- Res event number
- 96399
- Product code
- FMG
- Code info
- Catalog Number: 394910 UDI-DI code: 00382903949106 Lot Numbers: 4277968 4277973 4282451 4282461 4289801 4290582 4292904 4295848 4305108 4306700
- Firm FEI number
- 3012798826
- Recalling firm
- BD SWITZERLAND SARL
- Address 1
- 17 terre bonne park a4 route de crassier
- City
- Eysins
- Country
- Switzerland
- Additional info contact
- Krista DiPaula 410-598-9328
- 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)
- Root cause description
- Labeling Change Control
- Product quantity
- 500 units
- Distribution pattern
- 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
- 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.
- Action
On 02/20/2025, the firm sent via FedEx and/or email an "URGENT: Medical Device Product Recall MDS-25-5241" letter informing customers that BD confirmed that specific lots of BD Connecta BD Luer-Lok 360 were shipped to the U.S. market with Instruction for Use (IFU) labeling meant for Outside U.S. market. Customers are instructed to: 1. Locate any unused affected BD Connecta" BD Luer-Lok" 360, as listed in Table 1. 2. Remove the IFU from each shelf-box and destroy it. (OUS IFU version, Document number 500037734). 3. Insert a copy of Attachment 1 BD Connecta IFU Document Number: 500081278 (US IFU version). 4. Circulate this notice to all those who need to be aware within their organization or to any organization where the potentially affected products have been transferred. 5. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not customers have any of the impacted material so that BD may acknowledge their receipt of this notification. Report any questions or complaints experienced with the use of this product to BD via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT Email: productcomplaints@bd.com or bdrc55@bd.com
- K numbers
- K974083
- Harmonized identifiers (openFDA)
- Device name
- Stopcock, I.V. Set
- Medical specialty description
- General Hospital
- Regulation number
- 880.5440
- Device class
- 2
- K number
- K800862, K790010, K022895, K870261, K881805, K070143, K954984, K223175, K141254, K190539, K854348, K792126, K061143, K982368, K961982, K010217, K850280, K823373, K792125, K032393, K053405, K242255, K172266, K080077, K810375, K870324, K812927, K851986, K800864, K792128, K964435, K210516, K123084, K862691, K211204, K130245, K082106, K884435, K792124, K800284 +49 more
- Registration number
- 9616088, 9617594, 1061124, 1055236, 3006425876, 9616567, 3004111573, 3033589330, 1526863, 3013764800, 1518293, 9680794, 1625425, 2523676, 9613418, 3007738736, 3012798826, 2025816, 3032916632, 1018470, 2024024, 9614279, 9610847, 3003704957, 3010421104, 1060680, 3015173212, 3010432890, 1319639, 3002907620, 1423507, 2022435, 3045322464, 3007017524, 3012261967, 8020616, 1649914, 1713468, 3012809732, 1047429 +47 more
- FEI number
- 3002806588, 1000208624, 1000120555, 3006425876, 3002806901, 3001044237, 3003015552, 3004111573, 3033589330, 3001236905, 3003081151, 3013764800, 1526863, 1518293, 1625425, 3002806476, 1000138054, 3003076831, 2523676, 3007738736, 3012798826, 2025816, 3032916632, 3002879021, 1018470, 3003767881, 3003737899, 2024024, 3000215273, 3003040625, 3003058448, 3003704957, 3010421104, 3002807391, 3015173212, 3010432890, 3002907620, 2022435, 3045322464, 3002902735 +47 more