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
- Recall Number
- Z-0930-2021
- Event Number
- 86443
- Firm
- Braxton Medical Corporation
- FEI Number
- 3003499504
- Product Code
- FOZ
- Status
- Open, Classified
- Root Cause
- No Marketing Application
- Initiated
- September 4, 2020
- Address
- 15402 N Nebraska Ave, Ste 204, Lutz, FL, 33549-6149
Description
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.
Recalled products do not have FDA approval for sale in the United States.
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.
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.
1,781 cases