Z-1808-2025Class II

BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV...

Name: Z-1808-2025 BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV...
Creator: Becton Dickinson Infusion Therapy Systems, Inc.
Published: 2025-04-21
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2025-04-21 / Open, Classified / root cause: manufacturing process

FDA source

Becton Dickinson Infusion Therapy Systems, Inc. began a recall of 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... on 2025-04-21. FDA classified it as Class II and gives the reason as "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 -...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1808-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-21
Posted: 2025-05-21
Recalling firm: 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
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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: [email protected] 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: [email protected]
Quantity in commerce: 262,800
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.
Product 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1808-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1808-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-28	2025-05-21

Product code FOZ

K220584Class IIBD Cathena Safety IV CatheterBecton Dickinson Infusion Therapy Systems, Inc. / cleared 2022-03-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)