The Recall Desk
HighFDA (Devices)·Z-2589-2014·Announced 2014-09-10

Galt Medical Recalls Valved Tearaway Kits Due to Embolic Risk

Galt Medical Corporation is recalling 11,155 Valved Tearaway Kits because the adhesive could dislodge, posing an embolic risk to patients.

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 risk-of-harm product (embolic risk) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.

Plain-English summary

Galt Medical Corporation is recalling 11,155 units of the GALT VALVED TEARAWAY KIT (GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St). These sterile medical devices are used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.

The recall was initiated because the adhesive used in the product could dislodge when objects are inserted through the valve. This potential dislodgement could pose an embolic risk to the patient.

The affected units were distributed worldwide, including the United States (nationwide), Canada, Germany, the Netherlands, Ireland, Switzerland, France, Italy, and Greece. The specific catalog numbers involved are KIT-043-06 through KIT-043-11 and KIT-053-06 through KIT-053-22 (excluding KIT-053-13 through KIT-053-16).

The recalled product

Product
GALT VALVED TEARAWAY KIT GALT VTI w/ Sideport Stainless Steel Dbl Flex. J-St RX ONLY UNITS 1 STERILE EO Product Usage: Used in percutaneous procedures to introduce catheters and other intravascular devices into the peripheral vasculature.
Manufacturer
Galt Medical Corporation
Category
Medical Device — Vascular Access
Hazard
Affected units
11,155

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 (19)

  • Catalot Numbers: KIT-043-06
  • KIT-043-07
  • KIT-043-08
  • KIT-043-09
  • KIT-043-10
  • KIT-043-11
  • KIT-053-06
  • KIT-053-07
  • KIT-053-08
  • KIT-053-09
  • KIT-053-10
  • KIT-053-11
  • KIT-053-12
  • KIT-053-17
  • KIT-053-18
  • KIT-053-19
  • KIT-053-20
  • KIT-053-21
  • and KIT-053-22

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Galt Medical Corporation

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Same hazard · embolic risk

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