Z-0284-2020Class II

MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304...

Name: Z-0284-2020 MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304...
Creator: Becton Dickinson & Company
Published: 2019-04-10
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2019-04-10 / Terminated

FDA source

Becton Dickinson & Company began a recall of MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313... on 2019-04-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0284-2020
Classification: Class II
Status: Terminated
Initiated: 2019-04-10
Posted: 2019-11-04
Terminated: 2020-12-22
Recalling firm: Becton Dickinson & Co
Product: 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
Product code: FPA Set, Administration, Intravascular
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.
FDA 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 that they are also aware of the update to the disconnection technique of the BD MaxZero" and the associated extension sets. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification. 4. 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 Fishers Lane, Rockville, MD 20852-9787
Quantity in commerce: 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 Arabia Singapore Slovenia South Korea Spain Sweden Switzerland Thailand Turkey UAE United Kingdom.
Product codes and lots: All lots manufactured still within expiry.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0284-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0284-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-13	2019-11-04

Product code FPA

K171957Class IIMaxZero Extension Sets with Needless ConnectorCarefusion 303, Inc. / cleared 2017-07-19

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)