The Recall Desk
HighFDA (Devices)·Z-0075-2020·Announced 2019-10-16

Centurion PICC Line Accessory Kit Recalled for Fluid Droplet Risk

Centurion Medical Products is recalling PICC Line Accessory Kits containing a BD connector that may release fluid droplets upon 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 involves a medical device with a potential for fluid exposure, which fits the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Centurion Medical Products Corporation is recalling the PICC Line Accessory Kit (CVI4285) due to a defect in the BD MaxZeroNeedleess Connector included in the kits. The connector was recalled by the manufacturer because of the potential for droplets of fluid to separate from the sealed surface following disconnection.

The affected kits were distributed nationwide. The recall involves 181,965 units. Specific lot codes associated with the recall include 2018040690, 2018061490, 2018082790, 2018111490, 2018111990, and 2018120390.

Healthcare providers and consumers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions on the recall.

The recalled product

Product
PICC Line Accessory Kit CVI4285
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)

  • 2018040690 2018061490 2018082790 2018111490 2018111990 2018120390

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 →