Galt Medical Recalls Centeze Centesis Catheters Due to Bacterial Endotoxins
Galt Medical Corporation is recalling 300 units of Centeze Centesis Catheters because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is Class II, and the source text describes hazards that can produce fever, chills, and hypotension, which aligns with the rubric criteria for Severe severity involving significant injury reports or high-risk medical device defects.
Plain-English summary
Galt Medical Corporation is recalling 300 units of Centeze Centesis Catheters, catalog numbers DRC-006-05 and DRC-006-15. The affected lots are 18043101, 18124426, and 18120765.
The recall was initiated because the products might contain unsafe levels of bacterial endotoxins, also known as pyrogens, which were introduced during a manufacturing step. Bacterial endotoxins can activate the inflammatory process and produce fever, chills, and hypotension in a patient.
The recalled products were distributed in the United States to Minnesota, Pennsylvania, Virginia, California, Utah, Florida, New York, Georgia, Louisiana, Missouri, Texas, Mississippi, Ohio, Washington, Massachusetts, Illinois, Kentucky, North Carolina, and Puerto Rico. They were also distributed in Canada, Australia, France, Germany, Ireland, Italy, the Netherlands, Poland, Slovakia, Switzerland, Belgium, the United Kingdom, and Korea.
The recalled product
- Product
- Centeze Centesis Catheter, Catalog #: a) DRC-006-05, b) DRC-006-15,
- Manufacturer
- Galt Medical Corporation
- Category
- Medical Device — Catheter
- Affected units
- 300
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 (3)
- Lot #: a) 18043101
- b) 18124426
- 18120765
Distribution
Part of a larger recall action
This product is one of 8 recalled by Galt Medical 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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