The Recall Desk
HighFDA (Devices)·Z-0086-2020·Announced 2019-10-16

Centurion Medical Products Recalls Sterile Cap Change Kits

Centurion Medical Products is recalling sterile cap change kits because they include a connector that may leak fluid droplets 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 involves a medical device with a potential for fluid leakage, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Centurion Medical Products Corporation is recalling sterile cap change kits (model DYNDC1946B) because they include the BD MaxZeroNeedleess Connector. The connector was previously recalled by its manufacturer due to a potential for droplets of fluid to separate from the sealed surface following disconnection.

The recall covers 181,965 units distributed nationwide. The affected lots have codes 2018101790, 2018092790, and 2019030690.

Healthcare facilities and consumers should stop using these kits and contact Centurion Medical Products Corporation for instructions on return or replacement.

The recalled product

Product
STERILE CAP CHANGE KIT DYNDC1946B
Affected units
181,965

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)

  • 2018101790 2018092790 2019030690

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 33 recalled by Centurion Medical Products Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 33 products in this recall →