Z-0009-2023Class II

Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous...

Name: Z-0009-2023 Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous...
Creator: B Braun Medical Inc
Published: 2022-09-01
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2022-09-01 / Open, Classified / root cause: manufacturing process

FDA source

B Braun Medical Inc began a recall of Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access on 2022-09-01. FDA classified it as Class II and gives the reason as "Potential for leakage at the catheter hub". 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-0009-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-09-01
Posted: 2022-10-06
Recalling firm: B Braun Medical Inc
Product: Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Potential for leakage at the catheter hub.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On September 1, 2022, the firm notified customers of the recall via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine recalled product. Customers should return completed response forms to B. Braun Medical Inc. Once the form is received, B. Braun Customer Support will contact customers with instructions on returning any impacted product and provide credit and/or replacement of the product based on the individual customer's needs.
Quantity in commerce: 94,000 US
Distribution: Domestic distribution to AZ CA FL GA MD MI MO MS NC NY OH PA TN TX WA. Foreign distribution to Canada
Product codes and lots: UDI-DI (GTIN): 04046963318154 Lot Number/Expiration Date: 22D04G8241 01 Apr 2027 22D07G8241 01 Apr 2027 22D07G8242 01 Apr 2027 22E30G8241 01 May 2027 22E30G8242 01 May 2027

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0009-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0009-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-12	2022-10-06

Product code FOZ

K020785Class IIIntrocan Safety IV CatheterB.Braun Medical, Inc. / cleared 2002-08-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)