Date Initiated by Firm |
March 15, 2021 |
Create Date |
April 29, 2021 |
Recall Status1 |
Terminated 3 on June 07, 2022 |
Recall Number |
Z-1509-2021 |
Recall Event ID |
87585 |
510(K)Number |
K153293 K942988
|
Product Classification |
Set, administration, intravascular - Product Code FPA
|
Product |
Filtered Triple-Leg Extension Set - Intravascular administration set. Product Catalog number: 477034 - Product Usage: The extension set is a sterile, single-use intravascular direct injection, intermittent infusion, continuous infusion or aspiration of fluids and medications. |
Code Information |
Lot #: 00SL713784, 0061741483, 0061755034, 0061755296 |
Recalling Firm/ Manufacturer |
B. Braun Medical, Inc. 901 Marcon Blvd Allentown PA 18109-9512
|
For Additional Information Contact |
Tiffany Williams 610-596-2363
|
Manufacturer Reason for Recall |
BBMI has identified through complaints the potential for the extension set to become occluded or unable to prime.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
On 03/12/2021, B. Braun issued an Urgent Medical Device Recall notice via letter notifying customers of the potential for the extension set to become occluded or unable to prime. |
Quantity in Commerce |
1,900 units |
Distribution |
US Nationwide distribution in the states of NC, CA. |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = FPA and Original Applicant = B. BRAUN MEDICAL INC. 510(K)s with Product Code = FPA and Original Applicant = B. BRAUN OF AMERICA, INC.
|