Recall Z-0284-2020 ยท FPA Set, Administration, Intravascular
Becton Dickinson & Company
MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313 MZ5316 MZ8001 MZ8002 MZ8003 MZ9266 MZ9267 MZ9272 MZ9273 MZ9274 MZ9275 MZ9276 MZ9277 MZ9278 MZ9279 MZ9280 MZ9281 MZ9283 MZ9287 MZ9288 MZ9289 MZ9290 MZ9292 MZ9293 MZ9294 MZ9300 MZ9301 MZ9302 MZ9313
| Date | Apr 10, 2019 |
| Status | Terminated |
| Reason | BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection. |
| Root cause | Under Investigation by firm |
| Action | The firm notified customers of the recall via an Urgent Medical Device Correction letter. The letter informed customers of the potential for croplets of fluid to separate from the sealed surface of the BD MaxZero following disconnection, potentially exposing the healthcare professional, the patient, and the surrounding areas. Customers are asked to do the following: Please Take the Following Actions: 1. Immediately review your inventory for the specified Catalogues (Ref) listed in Attachment 1. 2. Share this communication with all users of the product within your organization to ensure t |
| Quantity | Pending |
| Distribution | Nationwide domestic distribution. Foreign distribution to Argentina Australia Austria Belgium Brazil Canada Chile China Colombia Croatia Cyprus Czech Republic Denmark Finland France Germany Hungary India Italy Japan Jordan Kuwait Lebanon Mexico Morocco Netherlands Norway Oman Poland Qatar Saudi Arab |
| 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 |