Stop using nowMedical device recall · FDA · Published September 4, 2020
B. Braun Introcan IV Catheters: FDA Unapproved for US Sale
B. Braun recalls sterile IV safety catheters sold in the US without FDA approval. Affected items have lot numbers ending in -01. Consumers should stop using these products immediately.
“B. Braun Introcan IV Catheters: FDA Unapproved for US Sale.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64377-b-braun-introcan-iv-catheters-fda-unapproved-for-us-sale. Based on FDA recall #Z-0930-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0930-2021%22&limit=1).
The FDA announced on September 4, 2020, that Braxton Medical Corporation is recalling B. Braun Introcan IV Safety Catheters because the products lack FDA approval for sale in the United States. The recall affects 1,781 cases distributed nationwide.
How to tell if you have it
Brand: B. Braun
Product: B. Braun Introcan IV Safety Catheters, sterile
Item codes ending in -01 with lot numbers: 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
Distribution: US Nationwide including AL, CA, CT, FL, GA, IL, KS, LA, MI, MN, NC, NJ, NY, PA, SD, TX, WA
The hazard
The recalled B. Braun Introcan IV Safety Catheters do not have FDA approval for sale in the United States. The device is a single-use product used to generate intravascular and tissue access to sample blood, monitor blood pressure, or administer fluids and blood intravascular.
Context
GovInfoNow's records show that Braxton Medical Corporation has been involved in other recent recalls of similar products, including Medline Convenience Kits with Unapproved Syringes Recalled (2026-02-27), Medline Convenience Kits with Unapproved Design Changes Recalled (2026-02-27), and Medline Convenience Kits with Unapproved Syringes: Recall for Design Changes (2026-02-27).
How to tell if you have this one
Check for lot numbers ending in -01, such as 4251601-01, 4251628-01, and other numbers listed in the recall notice. These products were sold as sterile IV safety catheters for medical use.
Brand
B. Braun
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
Immediately stop using the recalled IV safety catheters as they were sold without FDA approval in the United States.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 17 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA 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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, California, Connecticut, Florida, Georgia, Illinois, Kansas, Louisiana, Michigan, Minnesota, New Jersey, New York, North Carolina, Pennsylvania, South Dakota, Texas, Washington.
Recall timeline
FDA published this recall 5 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0930-2021 (September 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0930-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.