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U.S. Department of Health and Human Services

Class 2 Device Recall IV Safety Catheters

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  Class 2 Device Recall IV Safety Catheters see related information
Date Initiated by Firm September 04, 2020
Create Date January 27, 2021
Recall Status1 Open3, Classified
Recall Number Z-0930-2021
Recall Event ID 86443
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
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.
Code Information 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.  
Recalling Firm/
Manufacturer		 Braxton Medical Corporation
15402 N Nebraska Ave Ste 204
Lutz FL 33549-6149
For Additional Information Contact Felicia Stivers
813-901-8449
Manufacturer Reason
for Recall		 Recalled products do not have FDA approval for sale in the United States.
FDA Determined
Cause 2		 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 in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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