The Recall Desk
HighFDA (Devices)·Z-0284-2020·Announced 2019-11-13

Becton Dickinson Recalls MaxZero Extension Sets Due to Fluid Separation

Becton Dickinson is voluntarily recalling MaxZero Extension Sets with Needle-less Connectors because fluid droplets may separate from the sealed surface after disconnection.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (fluid separation) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

Becton Dickinson & Company has initiated a voluntary recall of MaxZero Extension Sets with Needle-less Connector. The recall covers specific product codes, including MZ1000, 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, and MZXT9004. All lots manufactured are still within their expiry dates.

The recall was initiated due to a confirmed complaint trend regarding droplets of fluid separating from the sealed surface of the MaxZero connector following disconnection. This issue was identified through a voluntary recall decision by the manufacturer.

The affected products were distributed domestically across the United States and internationally to numerous countries, including 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, and the United Kingdom. Healthcare providers and facilities should check their inventory for these specific product codes and stop using the affected extension sets.

The recalled product

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 MZ9

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots manufactured still within expiry.

Distribution

Distributed nationwide across the United States.