Centurion Medical Products Recalls Sterile Pitcher Kits Due to Seal Defects
Centurion Medical Products Corporation is recalling specific sterile pitcher kits because incomplete seals may compromise sterility. The products were 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 is classified as FDA Class II, and the hazard involves a risk of harm (compromised sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Centurion Medical Products Corporation is recalling specific sterile pitcher kits, including the GR100150ST Graduated Pitcher Sterile 1000 CC and the GR1200ST Sterile 1200CC Pitcher Kit. The recall is being conducted because incomplete seals on the sterile packages may compromise the sterility of the products.
The affected products were distributed nationwide and in Ghana. The specific lot codes involved are 2018121090 for the GR100150ST and 2019031990 for the GR1200ST.
Consumers and healthcare facilities should check their inventory for these specific product codes and stop using the affected units. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Centurion-Pitcher Kit GR100150ST GRADUATED PITCHER STERILE 1000 CC Y 2018121090 GR1200ST STERILE 1200CC PITCHER KIT Y 2019031990
- Manufacturer
- Centurion Medical Products Corporation
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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