BD Nexiva, BD Q-Syte recallZ-0125-2021 · Becton Dickinson & Company · initiated Sep 14, 2020
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
Dull/blunt needles within the IV Catheter System may lead to missed insertion attempts and delay in diagnosis or treatment until a new needle is inserted
FDA root cause category: Nonconforming Material/Component
What the company is doing
Siemens issued an "URGENT MEDICAL DEVICE RECALL" letter dated 9/14/20 to Distributors/Medical Facilities on 9/14/20 via FedX , email or faxed stating reason for recall, health risk and action to take: 1. Immediately review your inventory for the specific Catalog (Ref) and Lot number listed above. Destroy all product subject to the recall following your institutions process for destruction. 2. Share this recall notification with all users within or outside your facility network to which you may have further distributed the affected product to ensure they are also aware of this recall. 3. 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 per FDA requirements and subsequently process your product replacement. BD Customer/Technical Support, (844) 823-5433 Monday Friday between 8:30am and 5:00pm (EST) in the United States. For customers outside the US, contact your local BD representative or distributor.
Recall details
- Recall number
- Z-0125-2021
- Status
- Terminated
- Initiated by the company
- Sep 14, 2020
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 12,020 units
- Product code
- FOZ
- FDA submissions
- K183399
- Distribution
- US: Nationwide Distribution: AK, AR, AZ, CA, IL, KS, MO, NY, OH, UT, VA; and International to: Canada and Mexico.
Product description
BD Nexiva Closed IV Catheter System Dual Port (20 GA 1.75 IN) Catalog (Ref) No. 383538 BD Nexiva closed IV catheter systems are intended to be inserted into a patient s vascular system for short term use to sample blood, monitor blood pressure, or administer fluids.
Code information (models, lots, serial numbers)
Lot Number: 9325212 UDI: 30382903835387
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 383538Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall21 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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