Galt Medical Recalls Sterile Access Kits Due to Bacterial Endotoxins
Galt Medical Corporation is recalling specific sterile transcarotid and peripheral access kits because they may contain unsafe levels of bacterial endotoxins.
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 (bacterial endotoxins causing fever and hypotension) where the source text does not report any specific illnesses or injuries, fitting the High severity criteria.
Plain-English summary
Galt Medical Corporation is recalling specific lots of TVS LPA and Enhance Transcarotid/Peripheral Access Kits. These sterile, prescription-only medical devices were distributed in the United States and several international countries. The recall affects 8,350 units across specific catalog and lot numbers.
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 in patients, potentially causing fever, chills, and hypotension.
Healthcare providers and patients who have used these specific kits should contact Galt Medical Corporation for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03
- Manufacturer
- Galt Medical Corporation
- Category
- Medical Device — Surgical Kits
- Affected units
- 8,350
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 (16)
- Lot #: 1) a) G18046082
- G18046083
- G18046084
- G18046085
- b) G18031106
- G18031199
- G18046076
- c) G18030048
- G18030049
- d) G18030050
- G18030204
- 2) a) G18003035
- G18101170
- b) G18003036
- G18003037
- G18003038
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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