Centurion Umbilical Vessel Catheter Recall Due to Incomplete Seals
Centurion Medical Products is recalling Umbilical Vessel Catheter Insertion devices due to incomplete sterile package seals that 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 is classified as FDA Class II. The hazard involves compromised sterility, which poses a risk of infection (risk-of-harm product) without specific reports of injury or illness in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of Umbilical Vessel Catheter Insertion devices. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the medical devices.
The affected products are identified by lot numbers 2019050190 and 2019011790. These devices were distributed nationwide and to Ghana.
Healthcare providers and consumers should stop using the affected devices and contact Centurion Medical Products Corporation for further instructions or a return.
The recalled product
- Product
- Centurion- Umbilical Vessel UPC175 UMBILICAL VESSEL CATH. INSERTION UPC175 UMBILICAL VESSEL CATH. INSERTION
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Catheters
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 (2)
- Lot Numbers: 2019050190
- 2019011790
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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