FDA Medical Device Recalls (openFDA)
Braxton Medical Corporation: 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.
- Recall number
- Z-0930-2021
- 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.
- Status
- Open, Classified
- Initiated
- 2020-09-04
- Posted
- not on file
- Terminated
- not on file
- Reason
- Recalled products do not have FDA approval for sale in the United States.
- 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: documents@braxmed.com or Mail to: Braxton Medical Attn: Felicia Stivers, 15494 N. Nebraska Ave., Lutz FL 33549.
- Quantity
- 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.
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 3003499504
- Firm city
- Lutz
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28