FDA Medical devices recall ·
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN recall
- Recall number
- Z-1808-2025
- Date
- (initiated April 21, 2025)
- Company / brand
- Becton Dickinson Infusion Therapy Systems, Inc.
9450 S State St, Sandy, UT, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 262,800
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
REF/UDI-DI/Lot/Expiration: 386865/0100382903868650/4198480/30-Jun-2027, 386803/0100382903868032/4247809/31-Aug-2027, 386862/0100382903868629/4237744/31-Aug-2027
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.
States: Alabama Arizona California Florida Georgia Indiana Kansas Louisiana Massachusetts Maryland Minnesota Missouri Mississippi North Carolina New Jersey New Mexico New York Ohio Oklahoma Pennsylvania Tennessee Texas Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1808-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.