Galt Medical TVS LPA Recalled for Unsafe Bacterial Endotoxin Levels
Galt Medical Corporation is recalling TVS LPA devices 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 the hazard involves a risk-of-harm product (bacterial endotoxins causing fever and hypotension) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Galt Medical Corporation is recalling 3,530 units of TVS LPA devices (Catalog #: DIL-059-00) under FDA recall number Z-2564-2018. The affected units are from Lot #17338821 and Lot #18019045.
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 affected devices were distributed in the United States (MN, PA, VA, CA, UT, FL, NY, GA, LA, MO, TX, MS, OH, WA, MA, IL, KY, NC, and Puerto Rico) and internationally (Canada, Australia, France, Germany, Ireland, Italy, Netherlands, Poland, Slovakia, Switzerland, Belgium, United Kingdom, and Korea). Consumers and healthcare providers should check their inventory for these specific lot numbers and contact Galt Medical Corporation for further instructions.
The recalled product
- Product
- TVS LPA, Catalog #: DIL-059-00
- Manufacturer
- Galt Medical Corporation
- Affected units
- 3,530
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 (2)
- Lot #: 17338821
- 18019045
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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