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.
FDA Recall Z-0930-2021 · Posted None
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Recalling FirmBraxton Medical Corporation
Recall StatusOpen, Classified
Product CodeFOZ
Date Initiated2020-09-04
Product Quantity1,781 cases
Reason for Recall
Recalled products do not have FDA approval for sale in the United States.
Firm 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.
Root Cause
No Marketing Application
Distribution Pattern
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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