Galt Medical Elite HV Introducer Recalled for Bacterial Endotoxins
Galt Medical Corporation is recalling Elite HV Introducers due to potential 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 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 involves a risk-of-harm product (bacterial endotoxins) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
Galt Medical Corporation is recalling 10,950 units of Elite HV Introducers (Catalog #s: CLI-200-26, CLI-210-16, CLI-212-07, KCL-212-055) because they may contain unsafe levels of bacterial endotoxins, also known as pyrogens. These contaminants were introduced during a manufacturing step.
The affected products were distributed in the United States (including Minnesota, Pennsylvania, Virginia, California, Utah, Florida, New York, Georgia, Louisiana, Missouri, Texas, Mississippi, Ohio, Washington, Massachusetts, Illinois, Kentucky, North Carolina, and Puerto Rico) and internationally to Canada, Australia, France, Germany, Ireland, Italy, the Netherlands, Poland, Slovakia, Switzerland, Belgium, the United Kingdom, and Korea.
Bacterial endotoxins can activate the inflammatory process, potentially causing fever, chills, and hypotension in patients. The FDA has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected units and contact Galt Medical Corporation for instructions on return or replacement.
The recalled product
- Product
- Elite HV Introducer, Catalog #: a) CLI-200-26; b) CLI-210-16; c) CLI-212-07; d) KCL-212-055
- Manufacturer
- Galt Medical Corporation
- Category
- Medical Device — Introducer
- Affected units
- 10,950
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 (14)
- Lot #: a) 18032057
- 18032058
- b) 18001013
- 18046016
- 18162838
- c) 18019455 18019456
- 18019457
- 18019458
- 18019460
- 18047461
- 18047462
- 18047463
- d) 17363374
- 18116090
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.
See all 8 products in this recall →Related recalls
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