PlainRecordsBD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN…
- Reason
- Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.
- Status
- Ongoing
- Distribution
- Worldwide - US Nationwide distribution in the states of IN, AL, CA, FL, TX, NJ, MO, NC, NY, OH, AZ, MN, MA, WA, OK, KS, MS, LA, MD, GA, TN, NM, PA and the country of CA.
- Enforcement report date
- May 28, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Becton Dickinson Infusion Therapy Systems, Inc.
- Product
- BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
- Reason
- Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of IN, AL, CA, FL, TX, NJ, MO, NC, NY, OH, AZ, MN, MA, WA, OK, KS, MS, LA, MD, GA, TN, NM, PA and the country of CA.
- Quantity
- 262,800
- Codes and lots
- REF/UDI-DI/Lot/Expiration: 386865/0100382903868650/4198480/30-Jun-2027, 386803/0100382903868032/4247809/31-Aug-2027, 386862/0100382903868629/4237744/31-Aug-2027
- Recall started
- April 21, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Root cause (FDA)
- Process control
- What the company told customers
- On 4/21/2025, Removal notices were sent (mail/email/fax/phone) to Medical Directors, Risk Managers, Medical Device Safety Officers, Nurse Managers, and distributors were informed of the following: - Routine clinical practice of PPE should protect the clinician from mucocutaneous blood exposure. - If leakage from the septum occurs during insertion, the PIVC should no longer be used. It is recommended the clinician places a new PIVC. In addition, they were asked to do the following: 1) 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 previously used on a patient with no issues, no further actions are needed. 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 and return Customer Response Form via email to Email: BDRC6@bd.com 6. Distributors were asked to identify all customers within their distribution network that purchased any affected product. Then, Provide a copy of the attached customer letter to all customers to advise them of this field action notification. Questions or complaints can be reported to the North American Regional Complaint Center, 1-844-823-5433 Mon Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com
- Recall number
- Z-1808-2025
What the record says about this device
A simplified drawing of a device, following the words of FDA's record. It shows the reason the record gives, not a photograph of the product.
“Due to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which may cause blood exposure or the need for a second IV to be placed - which may result in therapy delay.”BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862, FDA enforcement report, 2025-05-28. The caption is the record's own words.
A generic device, not the product. The mark follows the record's own words.
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FDA device name: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Distributed in (FDA's record): Alabama Arizona California Florida Georgia Indiana Kansas Louisiana Maryland Massachusetts Minnesota Mississippi Missouri New Jersey New Mexico New York North Carolina Ohio Oklahoma Pennsylvania Tennessee Texas Washington and nationwide
This recall among the others
- FDA's enforcement report came 37 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Becton Dickinson Infusion Therapy Systems: 4 other recalls or notices on this site in the three years before this one (from May 29, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-1808-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1808-2025, May 28, 2025. "BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN." PlainRecords, https://plainrecords.com/recall/device/z-1808-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections