Recall Z-0930-2021 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
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.
| Date | Sep 4, 2020 |
| Status | Open, Classified |
| 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 submi |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.