Z-0930-2021Class II

B. Braun Introcan IV Safety Catheters, sterile -

Name: Z-0930-2021 B. Braun Introcan IV Safety Catheters, sterile -
Creator: Braxton Medical Corporation
Published: 2020-09-04
License: https://open.fda.gov/license/

Braxton Medical Corporation / initiated 2020-09-04 / Open, Classified

FDA source

Braxton Medical Corporation began a recall of B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor... on 2020-09-04. FDA classified it as Class II and gives the reason as "Recalled products do not have FDA approval for sale in the United States". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0930-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-09-04
Posted: 2021-01-27
Recalling firm: Braxton Medical Corporation
Product: B. Braun Introcan IV Safety Catheters, sterile - Product Usage: It is a single-use device to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Recalled products do not have FDA approval for sale in the United States.
FDA root cause: No Marketing Application
Action: On 9/4/2020 the firm sent a letter to its consignees with the following instructions. It has been brought to our attention that these products have not been approved by the FDA for sale in the United States. Please examine your inventory immediately and discontinue distribution of these products. Please identify and notify your customers that were shipped these products. Any remaining stock of these products should be quarantined and returned for a credit. Promptly complete the attached recall stock response form even if you have no product to return. Completed response forms can be submitted by any of the following methods: Fax to: (813)975-0611 or Email to: [email protected] or Mail to: Braxton Medical Attn: Felicia Stivers, 15494 N. Nebraska Ave., Lutz FL 33549.
Quantity in commerce: 1,781 cases
Distribution: US Nationwide distribution including in the states of AL, CA, CT, FL, GA, IL, KS, LA, MI, MN, NC, NJ, NY, PA, SD, TX, WA.
Product codes and lots: All lot numbers under item codes ending in -01: 4251601-01, 4251628-01, 4251652-01, 4251687-01, 4251890-01, 4252500-01, 4252519-01, 4252527-01, 4252535-01, 4252543-01, 4252560-01, 4252586-01, 4252594-01, 4253523-01, 4253540-01, 4254546-01.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0930-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0930-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-02-03	2021-01-27

Product code FOZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)