Galt Medical Recalls Vascular Dilators and Introducer Kits Due to Endotoxins
Galt Medical Corporation is recalling specific vascular dilators and introducer kits because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. The hazard involves unsafe levels of bacterial endotoxins which can cause significant physiological reactions including hypotension, fitting the criteria for a Severe rating.
Plain-English summary
Galt Medical Corporation is recalling specific lots of vascular dilators, tearaway introducers, and micro-access kits. The recall involves 9,050 units of these sterile, prescription-only medical devices. The affected products were distributed to healthcare facilities in 19 U.S. states and Puerto Rico, as well as to 13 countries including Canada, Australia, and the United Kingdom.
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 should check their inventory and patient records for the specific catalog and lot numbers listed in the official recall notice. If any of these devices have been used, patients should contact their healthcare provider if they experience symptoms such as fever, chills, or low blood pressure.
The recalled product
- Product
- 1) Vascular Dilator, Sterile EO, Rx Only, Catalog #: DIL-100-12; 2) Dilator, Sterile EO, Rx Only, Catalog #: DIL-600-11; 3) Tearaway Introducer, Sterile EO, Rx Only, Catalog #: a) INT-028-14; b) INT-028-24; c) INT-029-05; d) INT-106-01; e) INT-106-14; 4) Micro-Access Te
- Manufacturer
- Galt Medical Corporation
- Affected units
- 9,050
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 (20)
- lot #: 1) 18102478
- 2) 18033450
- 3) a) 18089973
- b) 18031311
- c) 18046318
- d) 18082001
- e) 18040777
- 18061334
- 4) S17342075
- 5) P18015009
- 6) S18051159
- S18072306
- 7) S18072307
- 8) a) S18033049
- S18064105
- S18093202
- S18096316
- b) S18025037
- S18032055
- S18032100
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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