CLASS II ONGOING Device recall · Reported 3 Feb 2021 · FDA Enforcement Report

B. Braun Introcan IV Safety Catheters, sterile recalled

Braxton Medical is recalling B. Braun Introcan IV Safety Catheters, sterile, distributed nationwide in the US. The recall was initiated on 4 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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.

Quantity recalled1,781 cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0930-2021
FDA event ID: 86443
Recalling firm: Braxton Medical, Lutz, FL
Classification: Class II
Status: Ongoing
Recall initiated: 4 Sep 2020
FDA classified: 27 Jan 2021
Reported: 3 Feb 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

4 Sep 2020	Recall initiated by company
27 Jan 2021	Classified by FDA	+145 days
3 Feb 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Recalled products do not have FDA approval for sale in the United States.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Alabama California Connecticut Florida Georgia Illinois Kansas Louisiana Michigan Minnesota North Carolina New Jersey New York Pennsylvania South Dakota Texas Washington

Questions about this recall

Why was it recalled?

Recalled products do not have FDA approval for sale in the United States.

Which lots are affected?

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.

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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