Agency classClass IIOur severity:Severe FDA (Devices)·Z-2559-2018·Announced 2018-08-08

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.

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 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…
Manufacturer: Galt Medical Corporation
Category: Medical Device — Vascular Access Devices
Hazard: bacterial-endotoxin
fever
hypotension
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

Distributed in 19 states:

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 →

Same manufacturer · Galt Medical Corporation

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Same hazard · bacterial endotoxin