Home / Recalls / Galt Medical Corporation / Z-0568-2021

Z-0568-2021 Class II Terminated

Recalled by Galt Medical Corporation — Garland, TX

Recall Details

Product Type
Devices
Report Date
December 23, 2020
Initiation Date
November 16, 2020
Termination Date
November 7, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9,920 catheters (updated on 03/17/2021)

Product Description

Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-002-06 Centeze Centesis Catheter, 6F, 10cm, 18Ga, 12cm, REF DRC-006-16

Reason for Recall

Due to a manufacturing issue, the catheter tip geometry is incorrect (thicker wall) resulting in a more obtuse tip angle.

Distribution Pattern

U.S.: FL, GA, MA, NC, NJ, OH, PA, Puerto Rico and UT. O.U.S: Canada, Netherlands, Turkey, United Kingdom, and UAE

Code Information

Catalog Number: DRC-002-06 Lot Numbers/UDI Code: 20108509/(01)0084 1268 100398(17)240428(10)20108509 20139676/(01)0084 1268 100398(11)200520(17)240519(10)20139676 20148911/(01)0084 1268 100398(11)200609(17)240608(10)20148911 20160253/(01)0084 1268 100398(11)200707(17)240706(10)20160253 20189100/(01)0084 1268 100398(11)200821(17)240820(10)20189100 Updated Information provided 03/16/2021: For Catalog Number: DRC-002-06 additional Lot Numbers: -20080351 -20234573 -20297230 -21008452 Additional Products: Catalog Number: DRC-006-16 Lot Numbers: -20217235 -20217236 -20217237

Other recalls by Galt Medical Corporation

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  • Z-1731-2025 Class II — GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended f (March 27, 2025)
  • Z-1737-2025 Class II — Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15 (March 27, 2025)
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  • Z-1735-2025 Class II — Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 0 (March 27, 2025)
  • Z-1969-2023 Class II — Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, IN (May 8, 2023)
  • Z-1968-2023 Class II — Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16 (May 8, 2023)
  • Z-2561-2018 Class II — 1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT (May 2, 2018)