Galt Medical Recalls Tearaway Introducers Due to Bacterial Endotoxins
Galt Medical Corporation is recalling specific lots of Tearaway Introducers because they may contain unsafe levels of bacterial endotoxins introduced during manufacturing.
What this means for you
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 medical device with a risk of harm (fever, chills, hypotension) due to bacterial endotoxins, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Galt Medical Corporation is recalling specific lots of Tearaway Introducers. The recall involves 23,777 units distributed across 19 U.S. states, Puerto Rico, and 13 international countries. The affected products include various catalog numbers such as BNS-000-07, DIL-015-50, and DSS-005-11, among others.
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.
Healthcare providers and consumers should stop using the affected lots immediately. The specific lot numbers are listed in the structured product information. Users should contact Galt Medical Corporation for further instructions or to return the products.
The recalled product
- Product
- Tearaway Introducers, Catalog #: a) BNS-000-07, b) BNS-000-10; c) DIL-015-50; d) DSS-005-11; e) DSS-005-12; f) DSS-006-045; g) DSS-007-05; h) DSS-007-165; i) DSS-010-03; j) DSS-010-04; k) DSS-010-045; l) DSS-010-05; m) DSS-012-07; n) SPT-003-46
- Manufacturer
- Galt Medical Corporation
- Affected units
- 23,777
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 #: a) 18024880
- 18043086
- 18066833
- 18073282
- b) 18039555
- 18059249
- 18074835
- c) 17363134
- d) 17352818
- 18051601
- e) 18019228
- 18047509
- f) 18023833
- g) 17356436
- 18018694
- 18018695
- 18040074
- h) 18061579
- i) 18015027
- j) 18019038
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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