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.

Company

Braxton Medical Corporation

Recall Initiated

September 4, 2020

Recall Number

Z-0930-2021

Quantity

1,781 cases

Firm Location

Lutz, FL

Reason for Recall

Recalled products do not have FDA approval for sale in the United States.

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 / Code Info

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.

Root Cause

No Marketing Application

Action Taken

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.