Date Initiated by Firm |
September 01, 2022 |
Date Posted |
October 06, 2022 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0009-2023 |
Recall Event ID |
90830 |
510(K)Number |
K020785
|
Product Classification |
Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
|
Product |
Introcan Safety FEP 14G, 2.2x32MM-US, Product Code 4251890-02. A passive anti-needle device to provide venous or arterial access. |
Code Information |
UDI-DI (GTIN): 04046963318154
Lot Number/Expiration Date:
22D04G8241 01 Apr 2027
22D07G8241 01 Apr 2027
22D07G8242 01 Apr 2027
22E30G8241 01 May 2027
22E30G8242 01 May 2027
|
Recalling Firm/ Manufacturer |
B Braun Medical Inc 200 Boulder Dr Breinigsville PA 18031-1532
|
For Additional Information Contact |
BBMI Postmarket Surveillance Department 833-425-1464
|
Manufacturer Reason for Recall |
Potential for leakage at the catheter hub.
|
FDA Determined Cause 2 |
Process control |
Action |
On September 1, 2022, the firm notified customers of the recall via Urgent Medical Device Recall letters. Customers were instructed to cease use and quarantine recalled product. Customers should return completed response forms to B. Braun Medical Inc. Once the form is received, B. Braun Customer Support will contact customers with instructions on returning any impacted product and provide credit and/or replacement of the product based on the individual customer's needs. |
Quantity in Commerce |
94,000 US |
Distribution |
Domestic distribution to AZ
CA
FL
GA
MD
MI
MO
MS
NC
NY
OH
PA
TN
TX
WA.
Foreign distribution to Canada |
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.
|
510(K) Database |
510(K)s with Product Code = FOZ and Original Applicant = B. BRAUN MEDICAL, INC.
|