Galt Medical Recalls Sterile Hemostasis Valve Introducer Systems Due to Endotoxins
Galt Medical Corporation is recalling specific sterile hemostasis valve introducer systems and kits because they may contain 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes potential physiological reactions including hypotension, which aligns with the rubric criteria for Severe severity involving significant injury reports or Class II classifications with serious health implications.
Plain-English summary
Galt Medical Corporation is recalling 3,160 units of specific sterile hemostasis valve introducer systems and kits, including the ELITE HV, Elite HV, AngioGate HV, and VSI Micro-HV models. The recall affects specific catalog numbers and lot numbers distributed across 19 U.S. states, Puerto Rico, and 13 countries internationally.
The products are being recalled because they 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 facilities should check their inventory for the specific catalog numbers and lot numbers listed in the official recall notice. If the products are found, they should be removed from service and returned to Galt Medical Corporation or the distributor.
The recalled product
- Product
- 1) ELITE HV, Hemostasis Valve Introducer System, Sterile EO, Rx Only, Catalog #: a) BCL-100-04; b) BCL-100-05; c) BCL-100-06; d) BCL-500-36; 2) Elite HV Introducer Set, Sterile EO, Rx Only, Catalog #: a) CLI-105-14; 3) AngioGate HV Introducer Kit, Sterile EO, Catalog #…
- Manufacturer
- Galt Medical Corporation
- Affected units
- 3,160
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 (11)
- Lot #: 1) a) S18015025
- b) S18015026
- c) S18015027
- d) S18046198
- 2) a) G17356364
- 3) a) S18016057
- S18106396
- b) S18080265 4) a) S18032092
- S18032093
- S18032094
- b) S18046163
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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