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Z-0284-2020 Class II Terminated

Recalled by Becton Dickinson & Company — Franklin Lakes, NJ

FDA device recall Z-0284-2020 was initiated by Becton Dickinson & Company on April 10, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated December 22, 2020). Affected quantity: Pending.

Recall Details

Product Type: Devices
Report Date: November 13, 2019
Initiation Date: April 10, 2019
Termination Date: December 22, 2020
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: Pending

Product Description

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 MZ9323 MZ9324 MZ9325 MZ9326 MZ9327 MZ9329 MZT1003 MZT1004 MZX5302 MZXT5303 MZXT5304 MZX5305 MZX5306 MZXT5306 MZXT5307 MZXT9001 MZXT9003 MZXT9004

Reason for Recall

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.

Distribution Pattern

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 Arabia Singapore Slovenia South Korea Spain Sweden Switzerland Thailand Turkey UAE United Kingdom.

Code Information

All lots manufactured still within expiry.

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