Recall Z-0076-2020 ยท LRS I.V. Start Kit
Centurion Medical Products Corporation
PEDIATRIC PICC INSERTION TRAY CVI4450
| Date | Apr 24, 2019 |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 Ad |
| Quantity | 181965 |
| Distribution | Nationwide domestic distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171957 | MaxZero Extension Sets with Needless Connector Carefusion 303, Inc., Jul 19, 2017 |