Centurion Driveline System Kit Recalled for Incomplete Sterile Package Seals
Centurion Medical Products is recalling 100 units of the Driveline System Kit because incomplete seals may compromise sterility.
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 risk-of-harm product (compromised sterility) where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling 100 units of the Centurion Driveline System Kit (TRIDM250), an outpatient driveline management system. The recall was initiated because incomplete seals on the sterile package may compromise the sterility of the device.
The affected products were distributed nationwide and in Ghana. The source text does not specify the exact dates of distribution or the specific facilities where the products were shipped.
Consumers and healthcare providers should stop using the affected kits and contact Centurion Medical Products Corporation for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Centurion- Driveline System Kit TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM
- Manufacturer
- Centurion Medical Products Corporation
- Hazard
- Affected units
- 100
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)
- TRIDM250 OUTPATIENT DRIVELINE MGMT SYSTEM 2019012890
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 54 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 54 products in this recall →Related recalls
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