Galt Medical Corporation
7 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Galt Medical Corporation and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-05-14FDA-DeviceClass IIIntroducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages.
Due to a potential open seal in the sterile barrier packaging.
- 2025-05-14FDA-DeviceClass IIIntroducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
Due to a potential open seal in the sterile barrier packaging.
- 2025-05-14FDA-DeviceClass IIIntroducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.
Due to a potential open seal in the sterile barrier packaging.
- 2025-05-14FDA-DeviceClass IIGALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vasculature.
Due to a potential open seal in the sterile barrier packaging.
- 2025-05-14FDA-DeviceClass IIB Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
Due to a potential open seal in the sterile barrier packaging .
- 2025-05-14FDA-DeviceClass IIB Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
Due to a potential open seal in the sterile barrier packaging .
- 2025-05-14FDA-DeviceClass IIGALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use in percutaneous fluid aspirations and small volume drainage procedures. For both adult and adolescent groups.
Due to a potential open seal in the sterile barrier packaging .
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