Centurion Port Draw Kit Recalled Due to Incomplete Sterile Package Seals
Centurion Medical Products Corporation is recalling 75 units of Port Draw Kits due to incomplete 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 involves a risk-of-harm product (compromised sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling 75 units of the Centurion Port Draw Kit (Lot Code: 2019061080). The recall was initiated because incomplete seals on the sterile package may compromise the sterility of the product.
The affected products were distributed nationwide and to Ghana. The recall is classified as Class II by the U.S. Food and Drug Administration.
Consumers who have this product should stop using it and contact Centurion Medical Products Corporation for instructions on how to return the product or obtain a refund.
The recalled product
- Product
- Centurion- Port Draw Kit KNV30 PORT DRAW KIT
- Manufacturer
- Centurion Medical Products Corporation
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 75
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)
- Lot Code: 2019061080
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.
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