BD Cathena Safety IV Catheter recallZ-0025-2024 · Becton Dickinson Infusion Therapy Systems Inc. · initiated Aug 29, 2023
Open, Classified
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 Infusion Therapy Systems Inc. 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
There is the potential that the safety shield may not properly engage on IV catheters. The needle can pull through the safety shield and disconnect from the needle safety shield leaving the contaminated needle point exposed.
FDA root cause category: Process change control
What the company is doing
On August 29, 2023, Becton Dickinson issued an "Urgent Medical Device Recall" notification via. FedEx. Becton Dickinson asked consignees to take the following actions: 1. Immediately review your inventory for Catalog Number 386862, Lot number 2238464. Destroy all unused product subject to the recall following your institution's process for destruction. 2. For indwelling catheters, no further action is needed. 3. If a defective product was used on a patient and the used needle was disposed of without the clinician suffering a needlestick injury, no further action is necessary to further protect the patient or the clinician. 4. Share this recall notification with all users within your facility network of the product to ensure they are also aware of this recall. 5. 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. 6. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch, Phone: 1-800-FDA 1088 (1-800-332-1088), Mail: MedWatch, HF-2, FDA, 5600 Fisher.s Lane, Rockville, MD 20852-978
Recall details
- Recall number
- Z-0025-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 29, 2023
- Posted by the FDA
- Oct 3, 2023
- Recalling firm
- Becton Dickinson Infusion Therapy Systems Inc.
- Quantity
- 98,000 units
- Product code
- FOZ
- FDA submissions
- K220584
- Distribution
- US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.
Product description
REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64 mL/min , Rx Only, Sterile EO
Code information (models, lots, serial numbers)
Lot # 2238464/ UDI-DI: (01)00382903868629
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- BD Cathena™ Safety IV Catheter 386862Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall206 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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