The Recall Desk
HighFDA (Devices)·Z-1968-2023·Announced 2023-06-21

Tearaway Introducer Kit Recalled Due to Potential Connector Defect

Galt Medical Corporation is recalling Tearaway Introducer Kits due to potential cracking or dislodging of the luer connection during use, which can render the device unusable and require replacement.

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: This is a Class II medical device recall with no reported injuries or illnesses. The hazard—a potential connector defect that could render the device unusable during clinical use—presents a risk of harm without reported adverse events, meeting the rubric criterion for High severity.

Plain-English summary

Galt Medical Corporation is recalling the Tearaway Introducer Kit (model references KIT-010-12, KIT-010-17, and KIT-900-16) due to a potential defect in the luer connection of the dilator hub.

Under improper storage conditions, the luer connection can crack or dislodge during clinical use, rendering the dilator component unusable and requiring replacement with another device.

The recall affects 490 units distributed in the United States and internationally to the United Kingdom, Australia, Turkey, France, Switzerland, and Norway. The FDA has classified this as a Class II recall.

If you have received one of these kits, contact Galt Medical Corporation regarding replacement or handling instructions.

The recalled product

Product
Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Manufacturer
Galt Medical Corporation
Category
Medical Device — Surgical Introducer
Hazard
Affected units
490

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 (6)

  • REF/UDI-DI/LOT (Expiration): KIT-010-12/00841268105195/S23104607(2/05/2027)
  • S22356870(1/11/2027)
  • KIT-010-17/00841268105249/S23083725(2/05/2027)
  • S22231321(9/08/2026)
  • S22328872(1/18/2027)
  • KIT-900-16/S22308637(1/04/2027)

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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 · connector defect

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