Date Initiated by Firm | April 24, 2019 |
Create Date | October 09, 2019 |
Recall Status1 |
Terminated 3 on April 03, 2020 |
Recall Number | Z-0092-2020 |
Recall Event ID |
83584 |
510(K)Number | K171957 |
Product Classification |
Cardiac catheterization kit - Product Code OES
|
Product | CVC BUNDLE, 20CM, 3L, PI
ECVC5120A |
Code Information |
2018032350 2018081050 2018091950 2018112750 2018121850 2019012450 2019013050 |
Recalling Firm/ Manufacturer |
Centurion Medical Products Corporation 100 Centurion Way Williamston MI 48895-9086
|
For Additional Information Contact | Lisa A. Carpenter 517-546-3356 |
Manufacturer Reason for Recall | Firm distributes kits which include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On April 24, 2019, the firm notified customers who had received kits containing BD's MaxZero product.
Customers were instructed to do the following:
1. Whether or not you have product in inventory, please complete and return the
attached Centurion Accountability Record via email- lcarpenter@centurionmp.com or
via fax-517-546-3356.
2. Please share this communication with all users of the product within your
organization, as directed in the BD letter.
3. Report any adverse health consequences experienced with the use of this product to
BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting
program.
Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-
800-332-1088); Mail: MedWatch, HF-2, FDA, 5600 Fisher's Lane, Rockville, MD 20852-
9787 |
Quantity in Commerce | 181965 total |
Distribution | Nationwide domestic distribution. |
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 = OES
|