Z-1397-2025Class II

Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter

Name: Z-1397-2025 Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter
Creator: B Braun Medical Inc
Published: 2025-02-17
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2025-02-17 / Open, Classified / root cause: manufacturing process

FDA source

B Braun Medical Inc began a recall of Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter on 2025-02-17. FDA classified it as Class II and gives the reason as "Increased risk for valve housing detachment causing leakage". 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-1397-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-02-17
Posted: 2025-03-19
Recalling firm: B Braun Medical Inc
Product: Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Increased risk for valve housing detachment causing leakage.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT MEDICAL DEVICE RECALL NOTIFICATION dated 2/13/25 was mailed to consignees notifying them of this product removal. Consignees are instructed to review the recall notification and to forward the notice along to those in their organization and to those to which product was further distributed. Consignees are to quarantine any affected devices in their inventory and coordinate product return by completion and return of the provided Product Recall Acknowledgement Form. Consignees with any questions are to contact B Braun at 844-903-6417.
Quantity in commerce: 28,200 units
Distribution: Domestic: CA, CA, FL, GA, IL, IL, IN, MD, MN, MO, NC, NM, NY, PA, TN, TX, VA, and WA; Foreign: Canada.
Product codes and lots: Model No 4251128-02; UDI-DI 04046964014017; Lot 24F09G8952.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1397-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1397-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-03-26	2025-03-19

Product code FOZ

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)