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U.S. Department of Health and Human Services

Class 2 Device Recall MaxZero

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  Class 2 Device Recall MaxZero see related information
Date Initiated by Firm April 10, 2019
Create Date November 04, 2019
Recall Status1 Terminated 3 on December 22, 2020
Recall Number Z-0284-2020
Recall Event ID 82453
510(K)Number K171957  
Product Classification Set, administration, intravascular - Product Code FPA
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
Code Information All lots manufactured still within expiry.
Recalling Firm/
Manufacturer
Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Customer Support
888-237-2762
Manufacturer 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 Determined
Cause 2
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.
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 = FPA and Original Applicant = Carefusion 303 Inc.
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