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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1731-2025 - GALT 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.
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2
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05/07/2025
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Galt Medical Corporation
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Z-1732-2025 - B 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 t...
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2
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05/07/2025
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Galt Medical Corporation
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Z-1733-2025 - B 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 introduc...
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2
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05/07/2025
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Galt Medical Corporation
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Z-1737-2025 - Introducer 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...
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2
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05/07/2025
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Galt Medical Corporation
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Z-1735-2025 - Introducer 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, 008412681...
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2
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05/07/2025
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Galt Medical Corporation
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Z-1736-2025 - Introducer Needle
REF NDL-107-04
These needles are used for the percutaneous introduction of guidewires
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2
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05/07/2025
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Galt Medical Corporation
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Z-1734-2025 - GALT 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 va...
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2
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05/07/2025
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Galt Medical Corporation
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