Class 2 Device Recall MaxZero

• Date Initiated by Firm: April 10, 2019
• Create Date: November 04, 2019
• Recall Status: Terminated 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: 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