|
Class 2 Device Recall BARD Magic3 GO |
|
Date Initiated by Firm |
April 20, 2023 |
Date Posted |
June 08, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-1701-2023 |
Recall Event ID |
92082 |
510(K)Number |
K150345
|
Product Classification |
Catheter, straight - Product Code EZD
|
Product |
HydroSil Go Intermittent Urinary Catheters, Catalog Numbers: a) REF 71808, b) REF 71810, c) REF 71812, d) REF 71814, e) REF 71816, f) REF 71818 |
Code Information |
a) REF 71808, Lot Numbers: JUGU9026;
b) REF 71810, Lot Numbers: JUGT9154, JUGU9053, JUGV9130, JUGV9133;
c) REF 71812, Lot Numbers: JUGT0236, JUGT1689, JUGT2702, JUGU1955, JUGU1968, JUGV9158;
d) REF 71814, Lot Numbers: JUGT3326;
e) REF 71816, Lot Numbers: JUGU9023;
f) REF 71818, Lot Numbers: JUGT0288, JUGU9022
|
Recalling Firm/ Manufacturer |
C.R. Bard Inc 8195 Industrial Blvd Ne Covington GA 30014-1497
|
For Additional Information Contact |
770-784-6100
|
Manufacturer Reason for Recall |
Some catheters had a manufacturing defect where the clear resealing label separating from the product foil pouch, resulting in a possible opening into the product packaging that could impact product sterility.
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
The firm issued an URGENT MEDICAL DEVICE RECALL to its consignee beginning on 04/20/2023 by Fed Ex and email. The notice explained the problem, risk, and requested the following actions be taken: Discontinue distribution of the product and dispose of all affected product, Distributors are directed to notify their customers.
For further assistance please contact: 1-844-8BD- LIFE (1-844-823-5433) Say "Recall" when prompted; M-F 8am - 5pm CT
|
Quantity in Commerce |
308520 devices |
Distribution |
Worldwide |
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 = EZD and Original Applicant = C.R. BARD, INC.
|
|
|
|