Z-0025-2024Class II

REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64...

Name: Z-0025-2024 REF: 386862, BD Cathena Safety IV catheter with BD Multiguard Technology, 20 GA 1.00 IN, 1.1 x 25 mm 64...
Creator: Becton Dickinson Infusion Therapy Systems Inc.
Published: 2023-08-29
License: https://open.fda.gov/license/

Becton Dickinson Infusion Therapy Systems Inc. / initiated 2023-08-29 / Open, Classified

FDA source

Becton Dickinson Infusion Therapy Systems Inc. began a recall of 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 on 2023-08-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0025-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-08-29
Posted: 2023-10-03
Recalling firm: Becton Dickinson Infusion Therapy Systems Inc.
Product: 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
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: 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: Process change control
Action: 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
Quantity in commerce: 98,000 units
Distribution: US Nationwide distribution in the states of CA, FL, GA, MA, MN, MO, MS, NJ, OH, TX.
Product codes and lots: Lot # 2238464/ UDI-DI: (01)00382903868629

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0025-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0025-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-10-11	2023-10-03

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)