BD Nexiva, BD Q-Syte recallZ-1710-2019 · Becton Dickinson & Company · initiated Mar 1, 2019
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Leak from the septum assembly or the canister may burst under high pressure which could result in blood exposure to a health care worker.
FDA root cause category: Release of Material/Component prior to receiving test results
What the company is doing
BD MDS (Medication Delivery Solutions) contacted via email and provided a hard copy letter via FedEx on March 1, 2019. The tetter describes the problem , action to take: Immediately review your inventory for the specific Catalog and lot number listed above.Destroy all product subject to the recall following your institutions process for destruction. Share this recall notification with all users of the product within your facility to ensure that they are also aware of this recall. . Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification and process your product replacement BD is requesting the distributor to identify their customers and either notify their customers regarding the recall or provide BD a customer list. BD will mail additional communications to the customers that are identified on the lists provided by the distributor. Questions: Customer/Technical Support 888-237-2762 OPT 3, OPT 2 Monday Friday between 8:00am and 5:00pm (EST
Recall details
- Recall number
- Z-1710-2019
- Status
- Terminated
- Initiated by the company
- Mar 1, 2019
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 6,720 units
- Product code
- FOZ
- FDA submissions
- K161777
- Distribution
- US distribution to one distributor in VA.
Product description
BD Nexiva Dual Port 20GA 1.00IN -Closed IV Catheter System intended for use in the peripheral vascular system Catalog Number: 383536
Code information (models, lots, serial numbers)
Lot Number: 8337721 Exp. 30-Nov-2021 UDI: 382903835362
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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