Centurion Medical Products Recalls Sterile Dressing Change Kits Due to Seal Defects
Centurion Medical Products is recalling specific sterile dressing change kits because incomplete seals may compromise sterility. The recall covers kits distributed nationwide and in Ghana.
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 (sterile medical device) where the defect (compromised sterility) poses a risk of infection, but the source text does not report any specific injuries or illnesses.
Plain-English summary
Centurion Medical Products Corporation is recalling specific lots of sterile dressing change kits, including CVC and PICC kits for NICU use. The recall is due to incomplete seals on the sterile packages, which may compromise the sterility of the products.
The affected products include the CVC Dressing Change Kit NICU (code BSICVC1005A), the PICC Dressing Change Kit NICU (code BSIPICC1002A), and the PICC Dressing Change Kit (code BSIPICC1003A). Specific lot codes associated with the recall are 2018103090, 2019021390, 2019041690, and 2019030190.
These products were distributed nationwide and in Ghana. Consumers and healthcare facilities should check their inventory for these specific product codes and lot numbers. If found, the products should be removed from use and returned to the distributor or manufacturer according to their instructions.
The recalled product
- Product
- Centurion- DRESSING CHANGE KIT BSICVC1005A CVC DRESSING CHANGE KIT NICU BSIPICC1002A PICC DRESSING CHANGE KIT NICU BSIPICC1003A PICC DRESSING CHANGE KIT
- Manufacturer
- Centurion Medical Products Corporation
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)
- 2019030190
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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