Centurion Circlamp

• • Ongoing Z-0133-2025 FDA Class II ·initiated 3 Sep 2024

  Product has been identified as having holes in the packaging.

• • Ongoing Z-2649-2023 FDA Class II ·initiated 23 May 2023

  The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.

• • Ongoing Z-1407-2023 FDA Class II ·initiated 2 Mar 2023

  The CirClamp subassembly found in the kit was the incorrect size.

• 2 recalls, same reason

  • Terminated Z-0120-2020 FDA Class II ·initiated 28 Aug 2019
  • Terminated Z-0121-2020 FDA Class II ·initiated 28 Aug 2019

  A mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.

• • Terminated Z-0837-05 FDA Unclassified (pre-2012) ·initiated 12 Apr 2005

  Not labeled as reprocessed, when this lot has been reprocessed.

• • Terminated Z-0836-05 FDA Unclassified (pre-2012) ·initiated 12 Apr 2005

  Lot 11224 may contain a 1.1 cm clamp and bell and neither lot is labeled as reprocessed, when they have been reprocessed.

510(k) Number

K890897 ↗

FDA Product Code

HFX

Device Class

Class II

Regulation

21 CFR Part 884.4530

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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  Unclassified

  FDA 510(k) K893647 Active Cleared 16 Oct 1989

• Infant Feeding Kit/Set Nasogastric Feeding Kit

  Class II

  FDA 510(k) K872096 Active Cleared 25 Aug 1987

• Centurion Disposable Instruments

  Class I

  FDA 510(k) K923812 Active Cleared 17 Dec 1992

• Centurion Kleen-Needle System I.V. Extension Sets

  Class II

  FDA 510(k) K910906 Active Cleared 1 Apr 1991

• Centurion Vaginal Speculum

  Class II

  FDA 510(k) K897100 Active Cleared 16 Mar 1990

• Centurion Specimen Trap W/Catheter

  Class I

  FDA 510(k) K872141 Active Cleared 26 Aug 1987

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