Centurion Medical Recalls Port and IO Access Dressing Kits
Centurion Medical Products Corporation is recalling Port and IO Access Dressing Kits because they include a connector recalled for potential fluid droplet separation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 separation, which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Centurion Medical Products Corporation is recalling Port and IO Access Dressing Kits (DT15780A). The recall involves 181,965 units that were distributed nationwide.
The kits include the BD MaxZeroNeedleess Connector, which was recalled by the manufacturer due to the potential for droplets of fluid separating from the sealed surface of the connector following disconnection.
The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- PORT AND IO ACCESS DRESSING KIT DT15780A
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Dressing Kits
- Hazard
- 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)
- 2018120690 2019012490 2019031190
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.
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